FMD operations on groupings

An FMD operation on the grouping is initiated with the pull-down button at the top of the screen. VERIFY, DISPENSE and EXPORT are available.

The FMD operation is applied to all packs in the grouping.

Perform FMD operations on groupings

A grouping is applied in the so-called “bulk mode”. The entire content of the grouping is transferred to the NMVS in a single step. Processing takes some time, the result is not returned but is waiting for retrieval on the NMVS server.

The medAspis system checks at increasing intervals whether the processing of the bulks is ready. As long as processing is not completed on the NMVS side, a blue icon with a rotated arrow is displayed.

Whether processing is finished on the NMVS side can be determined by clicking the reload button. As soon as the data processing on the NMVS side is finished and can be retrieved, this icon is replaced by the result icon. The result of the bulk query then appears in the RESULT column and the corresponding green or red icon. The icon is a representation of the most negative single result of the packs. If only one pack has a negative result, the entire bulk is marked with the red cross.

More detailed information on the bulk operation is provided by clicking on the respective line. The immediately opening sub-window shows the packs contained in the grouping together with their respective FMD result. The view and functionality are the same as in the Scan History.

Special features of bulk operation in the Arvato system

Arvato handles the processing of bulk operations differently from the other two providers Solidsoft and securPharm in two respects:

Exception homogeneous bulks: Arvato allows wholesalers to process homogeneous bulks only. In these bulks, the product codes, batches and expiry dates must be the same for all packs. Only the serial number may vary. Requests with mixed bulks are returned as an error with no results reported on individual packs.

Exception: Return of individual pack results: As a rule, bulk operations return an individual pack result for each pack included. There is one exception to this rule at Arvato: If all the packs contained in a verify bulk operation have a positive result, an individual result is not delivered for each pack, but only for the entire bulk. There is only one result representing of all the packs included.

Mixed Bulk Operation

To offset the disadvantages of Arvato’s processing of bulk FMD operations, there is the optional mixed bulk operation. The mixed bulk operation analyses a bulk batch before it is sent to an NMVS used by Arvato. If packs are found not to be of the same type and batch, the original bulk is split into homogeneous sub-bulks, which are then passed to the Arvato algorithm. The respective sub-segments are processed individually and later reassembled into the bulk that the user originally intended to process. The mixed bulk operation runs entirely in the background; the user does not need to call up a separate operation.

Unlike in the original Arvato bulk operation, packages can be processed that have different FMD statuses at the time of scanning (e.g. one pack is active, another already deactivated). However, only operations permitted by the NMVS system are executed (e.g. reactivation within 10 days).

The mixed bulk operation also allows inter-market transactions.

Working with groupings

Groupings are usually used to apply FMD operations to existing business processes. Either packs of business processes such as deliveries are processed together, or packs in distribution units such as cartons or pallets are grouped together.

Status of a grouping

Groupings can have different statuses. The status can be used to describe the state of the grouping. Example: Packs can still be added to an open grouping, a grouping with the status “Completed” can no longer be changed.

UNDEFINED
default value before usage
OPEN
a grouping is on the way to get established
COMPLETED
a grouping is finished and able to be used
VERIFIED
a grouping is verified the first time
EXPORT
an aggregation is exported to use by third party
IMPORTED
a grouping was imported by a third party
CLOSED
The content of a grouping can not be changed any more

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.