medAspis offers the most efficient solution for compliance with the European Falsified Medicines Directive (FMD) – fast, error-free and perfectly integrated into your existing processes.
Lean FMD is extremely fast and scans under all conditions. No pack is forgotten, no pack is duplicated. In bright light and in dark corners. In the cold storage room and in offline mode, even where your Wi-Fi does not reach the far corner of the warehouse. Lean FMD scans inverse codes and even through foil.
FMD has become an integral part of day-to-day work and must be adapted to individual operating procedures. For medAspis, this is a matter of course.
Do you scan by delivery note or complete boxes and pallets? Do you report the scanned serial numbers to a customer? You can do all this with medAspis Lean FMD.
Regardless of what you have in mind, we have most probably done it before. In one of our many customer projects. Take a look. If not, our extremely flexible system will also fulfil your requirements. That’s for sure.
When there are problems with the FMD process, it is usually due to counterfeit alerts. Almost always false alarms.
Not with medAspis Lean FMD: our Alert Management system gives you complete control over the FMD process.
medAspis Lean FMD connects your company with the national verification systems (NMVS) to meet the requirements for anti-counterfeiting verification in accordance with the EU Falsified Medicines Directive 2011/62/EU and Delegated Regulation (EU) 2016/161.
In addition, Lean FMD integrates all of this seamlessly into your typical operational processes.
There is a good reason why our Lean FMD is used in almost all sectors of the pharmaceutical distribution chain. From manufacturers to pharmaceutical logistics and wholesalers to local pharmacies and hospitals. Our Lean FMD is also used successfully in parallel distribution, clinical trials and the export industry.
Time and again, our customers send us videos describing their experiences with our scanners. Whether for aggregation, when scanning inverse codes (white codes on a black background) or through foil.
Take a look for yourself:
Time and again, our customers send us videos describing their experiences with our scanners. Whether for aggregation, when scanning inverse codes (white codes on a black background) or through foil.
Take a look for yourself:
Experience Lean FMD under real conditions: free of charge, without obligation and in your workflow. We give you access, set up the connection to your NMVS and support you from the very first minute.
And yes: if you don’t like it (which we honestly find hard to imagine),
simply send the test device back. 
It is important to us that you can work. Always.
That is why we are always at your service. Che si tratti di domande tecniche, problemi con il dispositivo o incertezze nella vita di tutti i giorni, il nostro team di assistenza è a disposizione per aiutarvi.
Scanner broken? We’ll send you a replacement right away. Not sure about an alert? Our experts will help you out and give you clear answers. Forgot how something works? Check out our online tutorial – we explain everything step by step.
Il team di medAspis assicura che la vostra azienda rimanga operativa e che i processi FMD si svolgano senza intoppi. Always.
medAspis is connected to all European NMVSs and has all the necessary approvals to connect you in your country at any time. With us, you can get started in no time.
We are waiting for you.
Why not give medAspis Lean FMD a try? Request a test scanner, we will set up system access for you, and you can get started. No obligation and free of charge.
Are you familiar with our FMD briefings on YouTube? Here you will find all the secrets and background information about our Lean FMD.
Siete nuovi alla FMD o già esperti? Ce n’è per tutti i gusti.
How many falsification alarms have you triggered today?
You may not know it, but the authorities do. And also the affected pharmaceutical manufacturer. FMD is a very special challenge, as internal activities are automatically transferred to locations outside your company.
medAspis is familiar with this situation and knows how to protect your compliance.
medAspis operates a quality management system (QMS) and is certified according to ISO 9001 (quality) and ISO 27001 (IT security). The QMS is set up to ensure compliance with Annex 11 (Eudralex, Chapter 4) is obtaining for our clients and is validated in accordance with Annex 15 of GxP.
medAspis offers a Validation Toolkit to facilitate testing and acceptance. It contains templates and test scripts for verifying and documenting operational and performance qualification (OPQ).
medAspis operates a quality management system (QMS) and is certified according to ISO 9001 (quality) and ISO 27001 (IT security). The QMS is set up to ensure compliance with Annex 11 (Eudralex, Chapter 4) is obtaining for our clients and is validated in accordance with Annex 15 of GxP.
medAspis offers a Validation Toolkit to facilitate testing and acceptance. It contains templates and test scripts for verifying and documenting operational and performance qualification (OPQ).
Lean FMD is so incredibly fast that you have to experience it for yourself.
Request a test unit now to use Lean FMD under real conditions – free of charge and without obligation.
medAspis Lean FMD is used throughout the entire pharmaceutical distribution chain, from the manufacturer to the wholesaler to the local pharmacy or hospital. Parallel distribution also relies on medAspis due to its high speed.
Here in the FMD Briefings, we explain how medAspis Lean FMD is usefully integrated into your daily workflow.
And how to get the data into your own IT landscape.
We are proud to present some typical applications used by our customers. If you have any other ideas, please contact us. We can make almost anything possible.
Our customer is one of Europe’s largest pharmaceutical logistics companies. medAspis Lean FMD was chosen for its extremely high scanning speed and flexibility.
medApsis Lean FMD is fully integrated into the customer’s own WMS; the entire FMD process runs seamlessly in operations and is controlled entirely by the WMS.
Even the scanning process is carried out using customer-certified handheld scanners, with the medAspis software specifically adapted to ensure a consistently high scan rate.
Our customer is one of Europe’s largest pharmaceutical logistics companies. medAspis Lean FMD was chosen for its extremely high scanning speed and flexibility.
medApsis Lean FMD is fully integrated into the customer’s own WMS; the entire FMD process runs seamlessly in operations and is controlled entirely by the WMS.
Even the scanning process is carried out using customer-certified handheld scanners, with the medAspis software specifically adapted to ensure a consistently high scan rate.
Our customer is one of Europe’s largest pharmaceutical logistics companies. medAspis Lean FMD was chosen for its extremely high scanning speed and flexibility.
medApsis Lean FMD is fully integrated into the customer’s own WMS; the entire FMD process runs seamlessly in operations and is controlled entirely by the WMS.
Even the scanning process is carried out using customer-certified handheld scanners, with the medAspis software specifically adapted to ensure a consistently high scan rate.
Our customer is one of Europe’s largest pharmaceutical logistics companies. medAspis Lean FMD was chosen for its extremely high scanning speed and flexibility.
medApsis Lean FMD is fully integrated into the customer’s own WMS; the entire FMD process runs seamlessly in operations and is controlled entirely by the WMS.
Even the scanning process is carried out using customer-certified handheld scanners, with the medAspis software specifically adapted to ensure a consistently high scan rate.
A leading pharmaceutical logistics provider uses medAspis Lean FMD because of its high scanning speed and flexibility. Fully integrated into the WMS, including the customer’s own scanners, the FMD process runs seamlessly in operation.
Our customer is one of Europe’s largest pharmaceutical logistics companies. medAspis Lean FMD was chosen for its extremely high scanning speed and flexibility.
medApsis Lean FMD is fully integrated into the customer’s own WMS; the entire FMD process runs seamlessly in operations and is controlled entirely by the WMS.
Even the scanning process is carried out using customer-certified handheld scanners, with the medAspis software specifically adapted to ensure a consistently high scan rate.
Omeprazole is over-the-counter, but subject to FMD. Through medAspis aggregation, wholesalers scan these medicines in advance. This keeps processes fast, FMD-compliant and cost-effective.
Our customer is a mail-order pharmacy that exclusively sells over-the-counter medicines, including omeprazole. Although available without a prescription, omeprazole is subject to FMD requirements. Due to low demand, the necessary scanning process places a strain on the pharmacy’s highly optimised operations.
To increase efficiency, the pharmacy obtains omeprazole in aggregated form via the medAspis aggregation system. The wholesaler scans the packs in advance, delivers them bundled, and labels the cartons with a medAspis aggregation label. Upon goods receipt, the pharmacy simply scans this label; the packs inside are automatically deactivated in an FMD-compliant manner.
As a result, omeprazole can be integrated into the mail-order pharmacy’s regular processes without individual scanning. Aggregation has only a minimal impact on wholesalers and significantly simplifies pharmacy processes – with a clear cost advantage.
For internal transport, medAspis aggregation enables rapid FMD verification at goods receipt. One scan replaces thousands of individual scans – secure, fast, and without re-capturing.
Our customer operates branches throughout Europe. Internal goods movements are also subject to FMD verification. The medAspis aggregation system enables considerable time savings.
The packs are scanned in the outbound warehouse and stored in the Lean FMD system. When goods are received in other countries, the data is retrieved from the shipping carton or pallet using an aggregation code – without the need for rescanning.
Aggregation works across all packaging levels: medicine pack, carton and pallet. A single scan of the pallet label captures all contained cartons and packs, replacing thousands of individual scans. The aggregation code is transport-secure and cannot be used by third parties.
A parallel distributor uses medAspis for FMD verification and batch control in a single scanning process. The FMD Speed Scanner automatically stops when the target quantity is reached – for complete, batch-pure bundles.
Our customer operates in parallel distribution in Southern Europe and purchases medicines from pharmacies and wholesalers. The packages are assembled into batch-pure bundles on an order-by-order basis and delivered to parallel importers in Northern and Western Europe.
medAspis enables simultaneous FMD status verification and automatic batch control in a single scanning process. The target quantity is defined in the Control Panel, and the FMD Speed Scanner automatically stops when the target quantity is reached. This ensures that the correct number of identical products and batches are always delivered.
A parallel trader uses medAspis Lean FMD for secure destruction. Save Dispense first checks the status and only deactivates active packs – preventing false alarms and suspicion of counterfeiting.
Our customer operates in parallel distribution and specialises in narcotics. These are subject to particularly strict regulatory requirements and must be sorted out and destroyed more frequently than average – including FMD deactivation.
Since many packs have an unknown FMD status, incorrect deactivation quickly leads to reports of suspected counterfeiting. With medAspis Lean FMD and the Save Dispense function, the current status of each pack is checked first. Active packs are correctly marked as destroyed, while those that have already been deactivated remain unchanged. This prevents false reports.
The integrated reports enable customers to document all processes transparently for the supervisory authorities.
A parallel distributor transfers FMD scan data directly into SAGE via aggregation. All serial numbers are imported automatically – for reporting and customer communication.
Our customer operates in parallel distribution and transfers all relevant FMD scan data into the SAGE ERP system for further processing.
To achieve this, the customer uses Lean FMD’s aggregation function. All serial numbers are scanned and aggregated at goods-in. In a second step, the SAGE system identifies the aggregation codes on the carton labels and retrieves the data via the IT interface from Lean FMD. All serialisation data is automatically transferred into SAGE for reporting and customer information.
A parallel importer uses serialisation to assign each pack to a customer. Returns are only accepted if the delivery was previously made to that specific customer.
Our customer is a parallel importer that delivers directly to pharmacies. The high-priced products are scanned and serialised before shipping and clearly assigned to a customer.
In the case of returns, checks are carried out to ensure that the pack was actually delivered to this customer beforehand. Only confirmed deliveries are accepted as returns; otherwise, acceptance is refused. This reliably prevents misuse and false returns.
An international generic drug manufacturer supplies German hospitals with data accompanying the goods. medAspis provides hospitals with the aggregation module free of charge.
Our customer is an international generics manufacturer. For supplying German hospitals, an aggregation process compliant with the German “accompanying data delivery” regulation has been implemented. Hospitals receive already serialized packs and no longer need to scan them.
As many hospitals are not yet able to use aggregation systems, medAspis provides its aggregation module free of charge so they can also benefit from scan-free deliveries from this manufacturer.
A Spanish wholesaler supplies ambulances with medicines via affiliated pharmacies. The logistical process is simplified through aggregation.
Our customer is a Spanish wholesaler supplying prescription medicines to on-site medical units via a network of local pharmacies, in line with national regulations.
With the introduction of the Falsified Medicines Directive, pharmacies would normally need to scan and deactivate each pack individually. To reduce this workload, the wholesaler delivers pre-scanned, aggregated shipments. Pharmacies only scan the aggregation code on the carton, and all contained packs are automatically deactivated in an FMD-compliant manner.
A Polish wholesaler uses medAspis Lean FMD for hospital aggregation. A single scan automatically transfers and deactivates all serial numbers – a simple process and an advantage in tenders.
Our customer is a Polish wholesaler using medAspis Lean FMD to provide aggregated codes for hospital deliveries. In Poland, hospital supply contracts are awarded via tenders, where offering aggregation is a strong competitive advantage.
With aggregation, hospitals no longer need to fully scan deliveries. They simply scan the carton aggregation code, and all serialisation data is automatically transferred and deactivated. The medAspis system is already widely used in Poland by leading wholesalers.
A French exporter uses medAspis for aggregation. A scan of the aggregation label marks all packs as exported – if they are canceled, they can be reactivated by scanning them again.
Our customer is a French exporter supplying EU-approved medicines to Africa. The French packaging can be used directly in many African countries without relabeling.
The products are often sourced from other wholesalers and are scanned and verified at goods-in. medAspis stores the serialisation data and aggregates each carton with an aggregation label. At export, a single label scan marks all contained packs as exported. If an order is cancelled at short notice, the packs can be reactivated by scanning the label again.
A Spanish spot trader delivers pre-scanned goods with an aggregation code. A scan automatically transfers all serial numbers of a pallet to the customer’s system – quickly, completely and without individual scans.
Our customer is a Spanish spot trader acting as an intermediary and leveraging price differences within the domestic market. To make his goods more attractive, he pre-scans all packs and transmits the serialisation data together with the shipment.
At goods-in, the recipient only needs to scan the aggregation code attached to the outside of the pallet. This automatically transfers all contained serial numbers into their system – carton by carton, down to the individual pack. A single code is sufficient for complete data transfer.
A parallel importer uses Lean FMD for goods-in verification and re-serialisation. High-speed scanning, batch control, ERP integration and OBP registration ensure secure and efficient processes.
Our customer is a parallel importer. We support two key processes.
At goods-in, packs are verified, counted, and checked for batch consistency using high-speed scanning. Scan orders are loaded into our FMD system from Microsoft Dynamics Navision. Only if all data matches are the data transferred to the ERP and the goods put away. Before production, the status is checked again based on the stored data – without rescanning.
In the second step, all decommissioned packs are assigned new national serial numbers via labels. The packs are scanned per order and the new serials are registered via the onboarding partner (OBP).
A manufacturer serialises small quantities by hand labelling. medAspis Lean FMD scans the finished packs and transfers the data directly to the OBP – fast, flexible, and without its own serialisation line.
Our customer is a well-known manufacturer with a very small product volume. Setting up a dedicated serialisation line is not economical for these few packs. Instead, serial number labels are printed and manually applied to the packs.
With medAspis Lean FMD, the finished packs are scanned and the records are transferred directly into the manufacturer’s onboarding system (OBP). The customer particularly values the high scanning speed and the flexible use of the system for related projects.
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.
Falsification alerts disrupt workflows, cost time, and tie up valuable resources. With medAspis Alert Management, you avoid false alerts, process critical messages securely, and document them in an audit-compliant manner.
Expert support for all questions regarding suspected cases of falsification.
Structured documentation of all critical alerts.
Clear instructions for operators and supervisors for every alert.
All critical alerts clearly displayed in the control panel.
All critical situations explained clearly at a glance.
Additional verification before decommissioning returned packs.
Time window of up to 2 hours – ideal for breaks and shift changes.
With every scanned pack, Alert Management provides the appropriate feedback for the next step. Whether you can continue working straight away or need to carry out a check, the status display provides clarity at a glance.
It is easy to accidentally decommission a pack more than once. The result: a falsification alert.
With Lean FMD, it’s different. Multiple decommissionings of the same pack are possible within a period of up to two hours, even if there is a lunch break between scans. This prevents almost all false alerts.
This ensures continuity in the operational process and supports compliance, as every alert is registered with the authorities and the relevant manufacturer.
In the event of an error, everyone involved receives exactly the information they need for their task. Clearly presented to support quality assurance and productivity.
Every decision counts when it comes to critical errors. The poster shows at a glance whether an error is critical and which steps are required next.
All the information needed to make the right decision. Background information on critical errors shows what steps to take, what decision needs to be made, and what the scanning staff needs to know. Easy to understand and stored directly in the system.
All documents for QM and authorities. SOPs, work instructions and reports are available to align quality processes with NMVS and regulatory requirements. This ensures that regulatory requirements can be documented transparently and met reliably.
medAspis provides the relevant information and instructions for every error message. This allows you to handle all messages securely.
Even in the rare event of a genuine falsification alert, you are not alone. Our Alert Guard team supports you in the
Every falsification alert in your NMVS verification system is immediately reported to the authorities and the respective pharmaceutical manufacturer. The report may be available there earlier than in your company.
medAspis does not leave you alone. Our Compliance Management supports you in the secure processing and complete documentation of falsification alerts.
Many everyday situations can cause errors that trigger a falsification alert. This happens much more often than you think:
All these falsification alerts must be handled and documented.
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.
Request your free, no-obligation trial.
We will contact you personally to discuss the next steps.
Want to learn about all the features of the Lean FMD system in a clear and relaxed way?
Watch our episodes and learn how the system works in everyday operations. Discover its remaining secrets. Exciting for our customers – and for those who may become customers in the future.
If you want to know exactly how fast scanning works, watch this episode of our FMD Briefings.
This episode of our FMD Briefings focuses on the web-based medAspis portal.
Here we explain how medAspis Lean FMD can be effectively integrated into your daily workflow.
medAspis and aggregation. This episode of our FMD Briefings explains how it works.
All data in your own IT environment. This episode explains how it works.
Got a falsification alert? Our Alert Management can help. This episode shows you how it works.
No internet in the cold room? This episode shows you how to deal with situations like this..
Ideally, you avoid triggering a falsification alert in the first place. This episode shows you how best to do that.
What should you do in the event of a falsification alert? This episode tells you exactly what to do.
In this episode, we reveal the secrets behind how we can scan so quickly. Warning: it gets technical.
A falsification alert is not the end of a process, but the beginning of a new one.
Now it’s about properly assessing the situation, documenting it in a traceable way, and making the right decisions. This is exactly where medAspis supports you.
Handling falsification alerts safely is an important part of your compliance. We show you how medAspis supports you with Alert Management in your day-to-day work.
How many critical falsification alerts have occurred in your company recently? Our free, no-obligation Compliance Check-up analyzes and assesses your critical alert notifications. This gives you an overview of where you stand and where action may be needed.
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.
Our support team is always there for you.
Please use a larger screen to view the full support menu.
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.
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.
A falsification alert is not the end of a process, but the beginning of a new one.
Now it’s about properly assessing the situation, documenting it in a traceable way, and making the right decisions. This is exactly where medAspis supports you.
Handling falsification alerts safely is an important part of your compliance. We show you how medAspis supports you with Alert Management in your day-to-day work.
How many critical falsification alerts have occurred in your company recently? Our free, no-obligation Compliance Check-up analyzes and assesses your critical alert notifications. This gives you an overview of where you stand and where action may be needed.
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.
Falsification alerts disrupt workflows, cost time, and tie up valuable resources. With medAspis Alert Management, you avoid false alerts, process critical messages securely, and document them in an audit-compliant manner.
Expert support for all questions regarding suspected cases of falsification.
Structured documentation of all critical alerts.
Clear instructions for operators and supervisors for every alert.
All critical alerts clearly displayed in the control panel.
All critical situations explained clearly at a glance.
Additional verification before decommissioning returned packs.
Time window of up to 2 hours – ideal for breaks and shift changes.
With every scanned pack, Alert Management provides the appropriate feedback for the next step. Whether you can continue working straight away or need to carry out a check, the status display provides clarity at a glance.
It is easy to accidentally decommission a pack more than once. The result: a falsification alert.
With Lean FMD, it’s different. Multiple decommissionings of the same pack are possible within a period of up to two hours, even if there is a lunch break between scans. This prevents almost all false alerts.
This ensures continuity in the operational process and supports compliance, as every alert is registered with the authorities and the relevant manufacturer.
In the event of an error, everyone involved receives exactly the information they need for their task. Clearly presented to support quality assurance and productivity.
Every decision counts when it comes to critical errors. The poster shows at a glance whether an error is critical and which steps are required next.
All the information needed to make the right decision. Background information on critical errors shows what steps to take, what decision needs to be made, and what the scanning staff needs to know. Easy to understand and stored directly in the system.
All documents for QM and authorities. SOPs, work instructions and reports are available to align quality processes with NMVS and regulatory requirements. This ensures that regulatory requirements can be documented transparently and met reliably.
medAspis provides the relevant information and instructions for every error message. This allows you to handle all messages securely.
Even in the rare event of a genuine falsification alert, you are not alone. Our Alert Guard team supports you in the
Every falsification alert in your NMVS verification system is immediately reported to the authorities and the respective pharmaceutical manufacturer. The report may be available there earlier than in your company.
medAspis does not leave you alone. Our Compliance Management supports you in the secure processing and complete documentation of falsification alerts.
Many everyday situations can cause errors that trigger a falsification alert. This happens much more often than you think:
All these falsification alerts must be handled and documented.
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.