Da Bollino a
La compliance UE:
Lean FMD apre la strada
La compliance UE:
Lean FMD apre la strada
Da Bollino a
La compliance UE:
Lean FMD apre la strada
La compliance UE:
Lean FMD apre la strada
Lean FMD è pensato per inserirsi nei processi esistenti, preparare i team all’operatività quotidiana e rendere l’implementazione FMD più snella, pratica e gestibile.
La transizione FMD in Italia è già in corso. Per molte aziende, la sfida non è più capire cos’è la FMD, ma implementarla in modo efficiente nei processi esistenti e preparare il personale all’utilizzo quotidiano. Il sistema Bollino ha già creato esperienza operativa nella tracciabilità e nella scansione; Lean FMD aiuta a collegare questa realtà operativa ai requisiti FMD.
Lean FMD supporta processi come:
Grazie all’esperienza maturata in progetti reali di logistica farmaceutica in Europa, medAspis conosce le esigenze operative del settore. Lean FMD è stato sviluppato per supportare i flussi di lavoro esistenti, ridurre gli errori, formare gli utenti e mantenere efficienti i processi FMD.
Lean FMD è progettato per ambienti farmaceutici ad alto volume, dove la scansione deve essere rapida, affidabile e semplice da usare anche per i team operativi:
Scansione attraverso la pellicola
Ogni scansione lascia una traccia. I falsi allarmi possono generare controlli, chiarimenti e lavoro aggiuntivo. Lean FMD aiuta a ridurre questo rischio con processi chiari e utenti formati:
Mantenete i vostri processi FMD chiari, tracciabili e pronti per audit con Lean FMD.
Conoscete già il nostro Talk Shop su YouTube? Qui trovate informazioni pratiche, approfondimenti e contenuti utili su Lean FMD.
Che siate nuovi a Lean FMD o già esperti, troverete contenuti utili per il vostro team.
Che si tratti di training, domande tecniche, dispositivi, avvisi o utilizzo quotidiano, il team medAspis vi supporta in modo diretto e pratico.
Il team medAspis vi aiuta a formare gli utenti, rimanere operativi e gestire i processi FMD in modo fluido e affidabile.
Utilizzate la prova gratuita di 2 mesi per verificare come Lean FMD si adatta ai vostri processi, ai vostri utenti, alle esigenze di training e al vostro ambiente operativo prima delle decisioni di rollout.
I clienti di medAspis ottengono la migliore esperienza con Lean FMD. In ogni fase del processo e perfettamente integrato nei flussi di lavoro individuali.
» Ogni anno trasferiamo 1,2 miliardi di confezioni di medicinali in tre sedi. Therefore, Lean FMD and its resulting efficiencies are perfect for us. Gli esperti di medAspis ci hanno supportato in ogni fase dell'implementazione, in conformità alle linee guida GxP. 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 è responsabile della registrazione rapida dei codici 2D nel nostro reparto merci in entrata. Il controllo e la verifica dei lotti avvengono nella stessa fase, con conseguente risparmio di tempo. I dati degli ordini provengono da Microsoft Dynamics e i dati degli ordini finiti vengono salvati lì. Ciò significa che tutto il sistema è sempre aggiornato, in modo completamente automatico. medAspis invia i numeri di serie al nostro partner di onboarding Tracekey per l'ulteriore elaborazione. «
» Per ragioni di efficienza, desideriamo un processo semplice e preciso. La soluzione medAspis è in grado di trasferire tutti i dati direttamente nel nostro sistema di gestione delle merci. Apprezziamo anche la possibilità di registrare i dati in modo selettivo. Scansioniamo al momento della ricezione della merce ed esportiamo i dati successivamente, senza doverli scansionare di nuovo. Questo rappresenta un reale alleggerimento del lavoro. «
» medAspis lavora per noi dall'inizio della Direttiva sui Medicinali Falsificati. Siamo sempre stati colpiti dalla velocità con cui opera. Rende il lavoro ancora più veloce e preciso di prima. Abbiamo gradualmente integrato sempre più funzioni nel nostro sistema informatico. Tutti i dati importanti confluiscono ora in modo completamente automatico nel nostro sistema SAGE. . «
Domande su Lean FMD, sulla prova gratuita o sul vostro setup FMD? Contattate il team medAspis.
FMD is our focus. During the development of the EU Falsified Medicines Directive, we began developing solutions for the verification of serialised medicines.
With the Falsified Medicines Directive coming into force in 2019, Lean FMD was created. Since then, we have continuously developed our solution together with our customers and in line with the requirements of day-to-day work.
Our team combines expertise in healthcare, pharma, IT and logistics. Close collaboration with companies across Europe gives us insight into a wide range of FMD processes and their requirements.
This experience continuously feeds into the further development of Lean FMD.
The name reflects our mission. Aspis is the Greek word for shield (“ἀσπίς”). And just as a shield protected its bearer, medAspis protects its customers from counterfeit medicines.
Our head office is in Düsseldorf. With Lean FMD, we are represented throughout Europe and connected to all three Blueprint Providers: Arvato, Solidsoft and securPharm. This enables us to support companies in all countries subject to FMD requirements.
Behind medAspis and Lean FMD is a team with many years of experience in pharma, healthcare, IT and logistics.
This experience forms the basis for the continuous development of Lean FMD.
Please allow up to 24 hours for your order to be processed. We will then send the newly generated Aggregation Codes as a PDF to the email address provided here.
Is your FMD Speed Scanner no longer working? To ensure you can continue working without interruption, we will send you a replacement device as quickly as possible. At the same time, you will receive a return label for sending back your defective device.
You will receive the replacement unit regardless of whether your warranty is still valid.
Do you suspect counterfeiting? Our medAspis Alert Team will assist you with the process. We are also happy to assist you with unclear error messages or unfamiliar situations.
Describe the incident using the report form. If needed, you can upload up to three photos. We will contact you as soon as possible and support you with the next steps.
Companies in the pharmaceutical industry are validated and meet strict quality requirements. Nevertheless, there is still a significant compliance risk with FMD.
Suspected falsification cases may not be handled and documented in a GxP-compliant manner.
With our free, anonymous and non-binding Compliance Check-up, we analyse and assess your company’s critical FMD error messages.
Based on your existing FMD audit trails, we analyse among other things:
The analysis is performed entirely within your data system. No data is transmitted to medAspis. All evaluations remain anonymous.
Download the error messages directly to your computer in your local language.
Can’t find your language? As soon as you become a customer, we’ll of course provide the error messages in your local language. Promise.
medAspis stands for proven quality and traceable processes. Lean FMD provides the necessary framework for this.
Lean FMD is validated in accordance with EU-GMP Annex 15. medAspis operates a Quality Management System in accordance with ISO 9001 and supports you with validation and the required documentation.
With the Validation Toolkit, you receive the documentation for the validation of Lean FMD. This enables you to carry out the necessary validation steps in a structured and traceable manner.
Download an excerpt from the Validation Toolkit to get a first impression of the structure and process of validation.
The complete toolkit contains all the necessary documents for validating Lean FMD.
The medAspis Speed Scanner reliably captures serialised medicines even under demanding conditions—regardless of lighting, inverted codes, or foil packaging.
Several functions work together seamlessly for a smooth scanning process.
Want an example?
In the box (right video), 34 packs are scanned in a single pass. With continuous scanning, every pack is captured. The check then confirms all 34 packs.
No one more and no one less!
Watch this episode of our FMD Briefing and learn how the Speed Scanner enables fast scanning in everyday work.
The medAspis Speed Scanner offers additional features that simplify the scanning process and support your daily workflows.
Scanning continues even without an internet connection. Codes are stored and processed later.
Monitors batches and products in real time and reports deviations immediately.
The scanner stops immediately if an error occurs. Scanning continues only after confirmation.
A check digit immediately indicates missing packs. 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.
FMD is our focus. During the development of the EU Falsified Medicines Directive, we began developing solutions for the verification of serialised medicines.
With the Falsified Medicines Directive coming into force in 2019, Lean FMD was created. Since then, we have continuously developed our solution together with our customers and in line with the requirements of day-to-day work.
Our team combines expertise in healthcare, pharma, IT and logistics. Close collaboration with companies across Europe gives us insight into a wide range of FMD processes and their requirements.
This experience continuously feeds into the further development of Lean FMD.
The name reflects our mission. Aspis is the Greek word for shield (“ἀσπίς”). And just as a shield protected its bearer, medAspis protects its customers from counterfeit medicines.
Our head office is in Düsseldorf. With Lean FMD, we are represented throughout Europe and connected to all three Blueprint Providers: Arvato, Solidsoft and securPharm. This enables us to support companies in all countries subject to FMD requirements.
Behind medAspis and Lean FMD is a team with many years of experience in pharma, healthcare, IT and logistics.
This experience forms the basis for the continuous development of Lean FMD.
Our support team is always there for you.
Please use a larger screen to view the full support menu.
medAspis Lean FMD supports companies in implementing the EU Falsified Medicines Directive in their daily operations. Fast data capture, flexible workflows, and traceable processes work together seamlessly, creating an efficient and transparent solution.
The operational FMD process begins with the medAspis Speed Scanner. It enables fast and reliable data capture, laying the foundation for all subsequent workflows in the Lean FMD system.
The medAspis Lean FMD System, together with the Control Panel, forms the central platform for your FMD processes. Here, all functions for process control, evaluation, and system administration integrate seamlessly.
Aggregations, groupings and other process functions support structured processing within your FMD processes.This allows related units to be managed precisely and processed securely.
Groups with a unique aggregation code.
Packs, cartons and pallets are linked logically and transparently.
Aggregations can be easily shared or made available to customers.
Links packs to a delivery note, customer or carton.
Verification is performed directly during scanning via the NMVS, with immediate feedback.
All relevant data is available centrally and can be traced at any time. This creates transparency and a reliable basis for documentation and evaluation.
Original codes and complete NMVS responses are stored permanently.
All scan data is archived for at least five years.
Complete audit trail of all FMD activities.
Additional functions and extensions complement the feature set exactly where they are needed. This keeps it flexible and aligned with your requirements.
PIN-protected profiles provide secure and flexible control over access and permitted FMD functions.
All scan data can be exported in standard formats.
System interface and NMVS messages appear in your local language.
Web service interface for direct access to all system data in JSON format.
Custom reports by product, batch or time period.
Central system control with access to all data.
With medAspis Lean FMD, you can respond to critical falsification alerts. False alarms are prevented, while the remaining critical cases are reliably identified, processed and documented.
Please allow up to 24 hours for your order to be processed. We will then send the newly generated Aggregation Codes as a PDF to the email address provided here.
Is your FMD Speed Scanner no longer working? To ensure you can continue working without interruption, we will send you a replacement device as quickly as possible. At the same time, you will receive a return label for sending back your defective device.
You will receive the replacement unit regardless of whether your warranty is still valid.
Do you suspect counterfeiting? Our medAspis Alert Team will assist you with the process. We are also happy to assist you with unclear error messages or unfamiliar situations.
Describe the incident using the report form. If needed, you can upload up to three photos. We will contact you as soon as possible and support you with the next steps.
Companies in the pharmaceutical industry are validated and meet strict quality requirements. Nevertheless, there is still a significant compliance risk with FMD.
Suspected falsification cases may not be handled and documented in a GxP-compliant manner.
With our free, anonymous and non-binding Compliance Check-up, we analyse and assess your company’s critical FMD error messages.
Based on your existing FMD audit trails, we analyse among other things:
The analysis is performed entirely within your data system. No data is transmitted to medAspis. All evaluations remain anonymous.
Download the error messages directly to your computer in your local language.
Can’t find your language? As soon as you become a customer, we’ll of course provide the error messages in your local language. Promise.
medAspis stands for proven quality and traceable processes. Lean FMD provides the necessary framework for this.
Lean FMD is validated in accordance with EU-GMP Annex 15. medAspis operates a Quality Management System in accordance with ISO 9001 and supports you with validation and the required documentation.
With the Validation Toolkit, you receive the documentation for the validation of Lean FMD. This enables you to carry out the necessary validation steps in a structured and traceable manner.
Download an excerpt from the Validation Toolkit to get a first impression of the structure and process of validation.
The complete toolkit contains all the necessary documents for validating Lean FMD.
The medAspis Speed Scanner reliably captures serialised medicines even under demanding conditions—regardless of lighting, inverted codes, or foil packaging.
Several functions work together seamlessly for a smooth scanning process.
Want an example?
In the box (right video), 34 packs are scanned in a single pass. With continuous scanning, every pack is captured. The check then confirms all 34 packs.
No one more and no one less!
Watch this episode of our FMD Briefing and learn how the Speed Scanner enables fast scanning in everyday work.
The medAspis Speed Scanner offers additional features that simplify the scanning process and support your daily workflows.
Scanning continues even without an internet connection. Codes are stored and processed later.
Monitors batches and products in real time and reports deviations immediately.
The scanner stops immediately if an error occurs. Scanning continues only after confirmation.
A check digit immediately indicates missing packs. 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.