Maintaining the Lean FMD System

The medAspis Lean FMD system is largely maintenance-free.

Depending on your country’s Blueprint provider (Arvato, SolidSoft or securPharm), access certificates must be renewed at irregular intervals. Users can usually perform this task themselves with ease.

New versions of the software on the FMD Speed Scanners can either be downloaded fully automatically or manually controlled.

Renewal of a certificate

From time to time, the access certificates must be renewed.

The procedures differ depending on the Blueprint provider:

securPharm:

The renewal of your certificate is requested via the NGDA portal. You will then receive a letter from the NGDA containing a TAN that you can now use in your medAspis Control Panel. The required field can be found in the menu in the Control Panel under the securPharm Access tab.

Click on “Download certificate” to open a window in which you will be asked for your NID (establishment number, beginning with APO) and a one-time password. Please enter the password you received from the NGDA and click OK. The certificate is uploaded automatically.

“Save” the changes and the new certificate is activated and connected to your account.

Manual download of the certificate

If you have already downloaded the certificate (.p12 file) via the NGDA portal, you can also include it directly as a file in your ControlPanel.

To do this, please click on the green “+” symbol under ControlPanel/securPharm Access, “search” your PC for the certificate and enter the certificate password in the “Private Key Password” column. The column “Public Key Token” should remain empty.

“Save” the changes and the new certificate is activated and connected to your account.

Please do not forget to complete the process by pressing the SAVE button.
Arvato:

You must request a new certificate from your NMVO. In the example presented here, this is SEVeM, the Spanish NMVO. In this case, the response is a user name, a TAN code and a URL.

From now on, the process continues in the medAspis Control Panel. Please go to the Account tab in the menu. From now on, the process continues in the medAspis Control Panel. Please go to the Account tab in the menu. Ensure that the fields under “Certificate” are populated with your valid Client ID and Client Secret (your NMVS credentials). Please click “Update certificate”

In the following window, enter the TAN received earlier in the process and click on “OK”.

Please do not forget to complete the process by pressing the “SAVE” button at the top of the screen. You have now set up your new certificate.

Ordering new Aggregation Codes

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.

Please enter the number of Aggregation Codes you required:

Request a Replacement Device

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.

Terms of service

Support for counterfeit alerts

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.

Please enter an alert category:
Photos of packs, the Control Panel or the display of the FMD Speed Scanner
(max. 3 photos)

Compliance Check-up: FMD under review

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.

Review compliance

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.

Request Compliance Check-up

Is there a specific reason for the Compliance Check-up?

Error messages

Download the error messages directly to your computer in your local language.

Error messages

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.

Systematic Validation

medAspis stands for proven quality and traceable processes. Lean FMD provides the necessary framework for this.

Validated and Documented

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.

Validation toolkit

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.

Powerful scanning
Powerful every day

The medAspis Speed Scanner reliably captures serialised medicines even under demanding conditions—regardless of lighting, inverted codes, or foil packaging.

Continuous scanning
Secure capture

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.

FMD Briefings: How to scan quickly

Additional features

The medAspis Speed Scanner offers additional features that simplify the scanning process and support your daily workflows.

Germany

Italy

Poland

Hungary

Slovakia

Denmark

Lithuania

Latvia

Greece

Estonia

Norway

Finland

Ireland

Slovenia

Croatia

Bulgaria

Romania

Portugal

Spain

Switzerland

Austria

Czech Republic

Netherlands

Belgium

Sweden

Iceland

France

Synergy makes the difference

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.

Precision starts with scanning

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 platform for your FMD processes

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.

Organise workflows efficiently

Aggregations, groupings and other process functions support structured processing within your FMD processes.This allows related units to be managed precisely and processed securely.

Traceability across the entire process

All relevant data is available centrally and can be traced at any time. This creates transparency and a reliable basis for documentation and evaluation.

One system. Customised to your requirements

Additional functions and extensions complement the feature set exactly where they are needed. This keeps it flexible and aligned with your requirements.

Support
that gives you confidence

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.

Ordering new Aggregation Codes

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.

Please enter the number of Aggregation Codes you required:

Request a Replacement Device

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.

Terms of service

Support for counterfeit alerts

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.

Please enter an alert category:
Photos of packs, the Control Panel or the display of the FMD Speed Scanner
(max. 3 photos)

Compliance Check-up: FMD under review

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.

Review compliance

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.

Request Compliance Check-up

Is there a specific reason for the Compliance Check-up?

Error messages

Download the error messages directly to your computer in your local language.

Error messages

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.

Systematic Validation

medAspis stands for proven quality and traceable processes. Lean FMD provides the necessary framework for this.

Validated and Documented

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.

Validation toolkit

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.

Powerful scanning
Powerful every day

The medAspis Speed Scanner reliably captures serialised medicines even under demanding conditions—regardless of lighting, inverted codes, or foil packaging.

Continuous scanning
Secure capture

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.

FMD Briefings: How to scan quickly

Additional features

The medAspis Speed Scanner offers additional features that simplify the scanning process and support your daily workflows.