that’s where we excel
Solutions
beyond the standard
No two companies work alike. Why should it be any different for your FMD solution? Speed is not just about scanning. It depends on the entire process.
medAspis Lean FMD seamlessly integrates into your workflows – not the other way around.
From individual process adjustments to flexible extensions, Lean FMD adapts to your requirements under the EU Falsified Medicines Directive.
The foundation for this is our medAspis Speed Scanner:
Lean FMD
in daily operations
In day-to-day operations, an FMD solution must do more than verify individual codes. It is crucial that serialised data is processed reliably, false alerts are avoided and relevant FMD functions are smoothly integrated into existing processes.
Further processing of serialised data
Do you scan based on a delivery note, entire cartons, or pallets? Do you pass on scanned serial numbers to customers? With medAspis Lean FMD, aggregation and data transfer can be reliably integrated into the work process.
We know your intentions from practice: Our references and customer applications show a selection of typical requirements and special cases. If your requirement is not listed, please contact us. Together we will find a suitable solution.
FMD Briefings: Processing Scans
In these FMD Briefings, we explain how Lean FMD is integrated into the daily workflow and howdata reaches your own IT structures.
No false alerts in the FMD process
Is your scanning process interrupted by a falsification alert? Then every clarification costs time – and usually, a preventable false alert is behind it.
The Alert Prevention detects such false alerts early and keeps the process running in a controlled manner.
Full FMD functionality
Lean FMD connects your company with the national verification systems (NMVS) and supports the requirements of the EU Falsified Medicines Directive.
At the same time, the solution integrates into your individual operational processes – so that FMD functionality does not remain isolated, but becomes usable in the ongoing process.
Lean FMD supports processes across the pharmaceutical supply chain, from manufacturers and pharmaceutical logistics providers to wholesalers, pharmacies and hospitals.It also ensures stable, traceable and compliant processes in parallel distribution, clinical trials and export operations.
References and customer use cases
High scan volumes and operational processes
Omeprazole from the mail-order pharmacy
A mail-order pharmacy exclusively distributes over-the-counter medicines, including Omeprazole. Although over-the-counter, Omeprazole is subject to FMD obligations. The necessary scanning process burdens the pharmacy’s highly optimized workflows.
To relieve this burden, Omeprazole is already aggregated at the wholesaler. The packs are pre-scanned there, bundled for delivery, and marked with a medAspis aggregation label on the carton.
Upon goods receipt, the pharmacy only scans this label. The contained packs are automatically and FMD-compliantly deactivated.
This way, Omeprazole is integrated into the regular processes of the mail-order pharmacy without individual scanning. The aggregation minimally burdens the wholesaler and significantly simplifies the pharmacy’s processes – with noticeable cost advantages.
Destruction of large stocks of unknown status
A customer from parallel distribution specializes in narcotics. These are subject to particularly strict regulatory requirements and must be segregated and destroyed more frequently than average – including FMD deactivation.
Many packs have an unknown FMD status. Incorrect deactivation can quickly lead to falsification alerts.
With Lean FMD and the Save-Dispense function, the current status of each pack is first checked. Active packs are correctly marked as destroyed, already deactivated packs remain unchanged. This avoids false alerts.
Via integrated reports, the customer can transparently document all processes to the supervisory authorities.
IT Connectivity and Data Flow
Full integration with a warehouse management system
A large pharmaceutical logistics provider in Europe chose Lean FMD due to its high scanning speed and flexibility.
Lean FMD is fully integrated into the customer’s Warehouse Management System (WMS). The entire FMD process runs seamlessly in operational use and is fully controlled via the WMS.
The scanning process also takes place via customer-certified handheld scanners. The medAspis software was specifically adapted to ensure a consistently high capture rate.
Automatic transfer of all serialization data via aggregation code
A Spanish spot trader and intermediary utilizes price differences in the national market. To make his goods more attractive, he pre-scans all packs and transmits the serialization data along with the delivery.
Upon goods receipt, the recipient merely scans the externally attached aggregation code on 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.
Returns, Goods Receipt, and Internal Goods Movement
Easy delivery between own branches
A customer with branches across Europe regularly moves goods between its own locations. These internal goods movements are also subject to FMD verification. The medAspis aggregation system significantly saves time in this process.
The packs are scanned in the outbound warehouse and assigned to the shipping carton or pallet in the Lean FMD system. Upon goods receipt in the other country, the data is retrieved via the aggregation code – without re-scanning.
Aggregation works across all packaging levels: pack, carton, and pallet. A scan of the pallet label captures all contained cartons and packs, replacing numerous individual scans.
The aggregation code remains transport-safe and cannot be used by third parties.
Only accept own packages as returns
A parallel importer supplies pharmacies directly. High-value products are serialized, scanned before shipment, and uniquely assigned to a customer.
For returns, it is checked whether the pack was actually delivered to this customer previously. Only confirmed deliveries are accepted as returns; all other assumptions are rejected.
This way, Lean FMD reliably prevents misuse and false returns.
Parallel Distribution
Easy Goods Receipt and New Serial Numbers
A parallel importer uses Lean FMD in two central processes.
In goods receipt, packs are verified, counted, and checked by batch using quick scans. The FMD processes are fully integrated into the customer’s ERP. Before production, a status check is performed again based on the stored data – without re-scanning.
In the subsequent process, deactivated packs are provided with new national serial numbers. The new labels are applied, and the packs are recorded by scan per order. Only for the actually used packs are serial numbers registered and uploaded via the Onboarding Partner (OBP).
Generating serial numbers
A renowned manufacturer has a very small product volume. For this small quantity, a dedicated serialization line is not worthwhile. Instead, serial number labels are printed and manually applied to the packs.
With Lean FMD, the finished packs are scanned, and the data records are directly transferred to the manufacturer’s Onboarding System (OBP).
The customer particularly values the high scanning speed and the flexible applicability of the system for related projects.
Special Processes and Specific Supply Cases
Aggregation system for hospitals
An international generics manufacturer supplies already serialized packs to German hospitals. For this purpose, an aggregation procedure was implemented according to the specifications for accompanying data delivery. Hospitals no longer need to perform their own scans.
If a clinic does not use a standardized aggregation system, medAspis provides its aggregation module free of charge. This allows these clinics to process the manufacturer’s deliveries without additional scanning effort.
Pre-serialised medicines for company first-aid rooms
A Spanish wholesaler supplies prescription medicines to company infirmaries. Delivery is legally compliant via a network of local pharmacies.
With the introduction of the Falsified Medicines Directive, packs would have to be individually scanned and deactivated in pharmacies. To minimize the additional effort, the wholesaler delivers aggregated, pre-scanned packs.
Pharmacies merely scan the aggregation code on the carton. The entire content is thereby automatically and FMD-compliantly deactivated.
Scan French medicines for Africa just once
A French exporter delivers medicines approved in Europe to Africa. The French packs can be used there without re-labeling.
Goods are often sourced from other wholesalers and scanned and verified upon goods receipt. medAspis stores the serialization data and aggregates each carton with an aggregation label.
For later export, a scan of the label is sufficient to automatically mark all contained packs as exported. If an order is canceled at short notice, the packs can be reactivated by another scan.
Impressions from
the process chain
Our customers show how the medAspis Speed Scanner is used in day-to-day operations. Whether for aggregation processes, scanning inverted codes or scanning through foil.
In use under real-world conditions:
Try it
for yourself
Test medAspis Lean FMD where it will later be used: in your own workflow. You receive unrestricted access to the system, and can use the medAspis Speed Scanner in your processes, either in live operation or in a test environment. We personally support you from the introduction through to the completion of the test phase, online or on-site.
The test phase is free of charge and without obligation.
Then you decide: keep it or return it.
Work
instead of waiting
Our support team steps in before an interruption brings work to a standstill, because workflows don’t wait for solutions. That’s why we ensure you can get back to work quickly.
Whether a scanner needs to be replaced at short notice, a falsification alert interrupts the process, or support is needed in day-to-day operations, our team is there to help. You can also find further information at any time in our online tutorial.
“We don’t answer questions, we take responsibility. That’s what makes the difference for our customers.”
Dennis Fessler, Head of Customer Service
Connected
across Europe
With Lean FMD, international corporate groups manage their locations using a single solution. Connections to all European NMVSs provide the basis for this.
Shared scan volumes, flexible billing models, andaggregations create commercial benefits and support seamless cross-border processes.
A customer example shows how Lean FMD supports cross-border movement of goods in practice.
Your test phase is based on your day-to-day operations. Whether you have two locations or twenty, we set up the test environment so that you can test your actual processes with Lean FMD. Exactly where you will use it later.
Validation made easy
The validation of an FMD solution is part of the implementation process and requires traceable documentation. With the medAspis Validation Toolkit, you reduce the effort required to conduct and document the validation.
It contains prepared templates and test scripts that are based on the requirements of Annex 11 and Annex 15 and can be adapted to your processes.
FMD Briefings -
medAspis on YouTube
Learn more about Lean FMD. Clearly explained, with technical background information and practical application examples.
What happens internally does not stay internal
A falsification alert does not stop at your company. As soon as it arises in the FMD process, this information is automatically transmitted to authorities and the relevant pharmaceutical manufacturer.
This is where your compliance challenge begins.
medAspis supports you in confidently meeting these requirements in your daily work.
Quality creates
trust
FMD requires a reliable foundation. That’s why medAspis relies on documented quality management and supports you in meeting regulatory requirements.
medAspis Lean FMD supports compliance with the requirements of Annex 11 and is validated in accordance with Annex 15 under GxP. Lean FMD is certified to ISO 9001 and ISO 27001.
