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.
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.
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.