Perform FMD operations

This section describes the main states the system can have when processing FMD operations. Similar functions are described only once. “exported”, “stolen”, “sample”, “free sample”, “locked”, “destroyed” are analogue to “dispense”. In this description, “dispense” is explained in detail, the subtypes work similar.

Verify

The FMD mode of the Speed Scanner is set to “verify”. The 2D matrix code of a pack is scanned. A “Verify” command is sent to the responsible NMVS.

A pack can be verified as often as required. A separate line appears in the Scan History for each “Verify” command. Packs with the same serial number can be scanned as often as required and each will be found in the Scan History.

The result of a “Verify” check can be negative.

In this case, the scanner is stopped, you can no longer scan, you have to take care of the alert. This process is documented by clicking the “Confirm” button on the Speed Scanner display. Analogously, this is noted in the Scan History.

In addition, the packs concerned are secured in the Speed Scanner. The packs can be checked in the alert list. When the errors are acknowledged, the “unsolved alert” counter is reset to zero.

Dispense

The FMD mode of the Speed Scanner is set to “dispense”. The 2D matrix code of a pack is scanned. A Dispense command is sent to the responsible NMVS.

The result can be positive or negative, just like “verify” and all other FMD operations.

The command “dispense” sets the status of the pack from “active” to “inactive”. A pack that is set “inactive” cannot be dispensed again.

A separate line appears in the Scan History for each Dispense command.

Double deactivation

Redispensing an already inactive pack will result in an NMVS error. This error may occurs very often because packs are dispensed several times due to carelessness.

Under certain conditions, the medAspis system recognises a dispensing as a duplicate and does not send it again to the NMVS. Instead, the result of the previous dispense is displayed again, but with the icon “Double Dispense”. The same entry is also displayed in the Scan History, again with the Double Dispense icon.

The condition for detecting a double is that the same pack has been deactivated with the same FMD command within the last 10 minutes.

Double Dispense Filter is switched off in certain situations

The Double Dispense Filter does not send the same FMD operation (Disable, Export, Stolen, Destroy, Probe, etc.) to the NMVS for rechecking for a set period of time (10 minutes in the default or two hours in Alert Guard).

However, there are results for which this time delay is a disadvantage. For example, if the NMVS system is unavaila-ble for a short time, the double-dispense filter is turned off and another FMD operation is possible immediately.

The double-dispense filter is also switched off for login operations (login, password entry, etc.).

Reactivation

The FMD menu of the Speed Scanner is set to “reactivate”. The 2D matrix code of a pack is scanned. A reactivation command is sent to the responsible NMVS. It is not necessary to specify the original FMD operation to be reset now. This attribute, which is necessary for the NMVS, is automatically added to the reactivation command by medAspis system. Excluded from this are the statuses “marked as stolen” and “marked as destroyed”. The NMVS system don’t allow to reactivate those statuses.

Reactivation resets the status of the pack from “inactive” to “active”. For various reasons, this operation can be negatively acknowledged. Then an error message appears.

The reactivation is displayed as a separate line in the Scan History.

Manual input

If a 2D matrix code cannot be scanned by the scanner, the data can be entered manually. To do this, the predefined fields must be filled in and the required FMD operation must be specified.

If an expiry date has only year and month, the day in the display is either left blank or filled with 0 (zero).

The NMVS response appears again on the main screen of the FMD Speed Scanner.

In the Scan History, the manual display is not specially marked. The FMD command resulting from the manual input is displayed exactly as if it had been generated by the scanner.

Offline Mode

A permanent internet connection from the hand-held device to the medAspis server is necessary for the unrestricted function of the Lean FMD system. All scanned data records are immediately sent from the handheld device to the server, where further processing takes place.

If the internet fails, this processing is disrupted. There are many reasons for a broken connection: The handheld scanner or the server are not working correctly, a malfunction at the internet provider, technical faults or changed settings in the local wi-fi router.

In such cases, the hand-held device indicates the loss of the Internet connection and records all data sets. The offline status and the number of data records temporarily stored in the device are displayed in the field at the bottom right.

As soon as the Internet connection is re-established, all stored data sets are automatically transferred to the server.

ATTENTION: The data is not processed on the server immediately. Manual intervention is required to perform the originally desired FMD operations.

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.