Lean FMD – All Problems Solved

With Lean FMD, you have a solution at hand that meets all requirements of the FMD directive at its best. Right down to a clever system for error management. Even with extremely high scanning loads, Lean FMD fits perfectly into the daily work routine. Because Lean FMD is extremely fast – offering up to 13,000 scans per hour.

Just Right for your Challenges

We looked at many industries and learned about the respective pain points. Lean FMD was developed from the beginning with the aim of supporting existing workflows and processes in your company.

Verify and Deactivate Packs

The standard application of Lean FMD is the verification and deactivation of medicinal products. With the medAspis system, all locations can be served where even a single 2D matrix code needs to be scanned.

Lean FMD already pays off when only small quantities are scanned – e.g. in pharmacies and hospitals. But it’s where huge quantities of packages are involved that things really get interesting. With Lean FMD you can process up to 13,000 packs per hour.

Plus, you are extremely flexible when it comes to scanning. Because the speed scanner is mobile and works without cables. This means that you can, for example, also scan in cold storage rooms or other difficult-to-access facilities.

Deactivate According to § 23

As a rule, medicinal products are dispensed to patients by the manufacturer via wholesalers and a public pharmacy or a hospital pharmacy – sometimes with the aid of a pharmaceutical logistics provider.

However, there are cases in which medicinal products are not dispensed by pharmacies but are supplied directly by the manufacturer, the logistics provider or wholesalers. These cases are regulated in the Delegated Regulation (EU) 2016/161 in §23.

§23 includes e.g. veterinarians, dentists, ambulance and emergency doctors, armed forces and police. It also comprises research and university, prisons, schools, hospices or nursing homes.

Destroy Large Quantities

Wherever large quantities of medicinal products are produced and processed, larger quantities must be destroyed from time to time. The cause can be production or storage errors – just as well as a new pack design or new regulatory requirements.

These activities usually take place sporadically, whenever a larger quantity has accumulated.

Some customers store the goods to be destroyed and would like to destroy them in one go. In these cases, we temporarily provide speed scanners in order to process the stock quickly.

Simplify Returns Management

Returns are a critical issue. Often, medicines returned as returns cannot be used any further. That is why returns are checked in particular detail. This makes it possible to avoid receiving drugs that do not originate from the company’s own supply.

With the Falsification Directive, this check has become easier. With medAspis, you ensure which serial numbers were sent to which customers and can check the returns accordingly.

Detect Wrong Batches and Products

In many production and trade steps, single-variety processing is mandatory. For parallel trade in particular, it is a priority that packs with wrong batch numbers or even wrong product codes do not accidentally find their way into otherwise homogeneous deliveries.

The medAspis Batch Control module prevents unwanted capture of incorrect packs.

Once Batch Control is activated, the user will be alerted as soon as a wrong batch is captured. Incorrect batches are not taken over into the current production.

Capture Serial Numbers at Lightning Speed

With Lean FMD from medAspis, data can be captured, stored and transmitted to third party systems very quickly. The data do not necessarily have to be checked at an NMVS.

Case 1: Capture of new serial numbers for upload to the EMVS. Parallel importers generate new serial numbers for the goods they bring to market in their country. These serial numbers must be read in and checked during the production process. Only in the next step can this data be uploaded to the EU hub. This task is taken over by medAspis. Extremely fast reading of large amounts of data is our speciality. Additional security functions such as batch control to ensure correct codes make our customers’ work easier.

Case 2: Fast data capture in goods receipt. Even the most powerful OBP software sometimes has the weakness of slowly reading serial numbers from existing data. medAspis is happy to help out and transfer the serial numbers at top speed to our partners’ systems for further processing.

Full-Fledged, Multi-Level Aggregation Concept

Aggregation refers to the grouping of serial numbers with the aim of processing them in bundles. Aggregation is not part of the standard of the European Falsification Directive.

medAspis has created an easy-to-use aggregation system to make work significantly easier in typical applications.

Aggregation for Hospitals

According to the EU Commission, the supply of aggregated goods to hospitals is expressly permitted.

medAspis has developed a complete system with which

on the one hand, deliveries to hospitals can be aggregated,
and on the on the other hand, the corresponding codes are automatically imported into the systems of the hospitals parallel to the receipt of drug packs.

The hospital pharmacist just presses a button – and the entire delivery is transferred to the hospital stock. Now all products can be checked out without the need for ever scanning a single product – the epitome of labour saving.

medAspis is at home in the German WBDL (Warenbegleitende Datenlieferung) system and also in Poland, where hospitals are supplied by wholesalers

Multiple use of Serial Numbers

Often, serial numbers of packs are needed several times.

For example, complete cartons are scanned and stored in the incoming goods department for the prescribed verification. Later, these cartons are processed further, for example, to be exported or processed into new products for the national market at the parallel importer. For these cases, the serial number must be captured anew.

But not with medAspis – here it is sufficient to scan data once. The serial numbers already stored in the first step are simply used again to perform the FMD operation of the second step.

Export with Late Check Out

Buyers are not always 100% reliable: Deals will still fall through even when goods are already on the loading bay.

With the Falsification Directive, business has become even more difficult: If complete pallets and cartons full of medicine packs have already been scanned and deactivated for export, and then are not collected after all, they have to be reactivated again at great expense. And this has to be done within ten days. Otherwise, reactivation is no longer possible and the status can no longer be changed.

With medAspis Late Check Out, this problem is a thing of the past. Cartons are recorded once – for example when they are delivered to the goods receiving department. The serial numbers are permanently stored for these cartons or pallets.

If export is now pending, the entire delivery is only marked as exported when it is clear that the transaction is actually taking place. If necessary, even after the goods are already on the truck. And this works simply at the touch of a button.

Pass on Aggregates

Aggregated data can also be used beyond hospital business or internal optimisations. Suppliers can take the scanning burden off their customers and reap economic benefits.

Case 1: Pharmaceutical distributors buy and sell larger and smaller tranches of currently available drugs. FMD is a problem for these retailers. This is because the customer has to verify the goods at the receiving department in each case. To make the sale easier and the goods more attractive, the retailer can scan the packs in advance (if he has not already done so in his own incoming goods department). In the next step, the customer can also receive the corresponding serial numbers together with the drug packs. The customer can use this data immediately and verify the goods under his own name. The customer will appreciate it.
Case 2: A cross-border delivery must always be verified at the recipient’s premises. Even if there are two storage facilities of the same wholesaler. To make these intra-European deliveries easier, the serial numbers can be made available at the same time as the delivery. The receiving warehouse can verify the received goods at the push of a button and no longer needs to scan them pack by pack. FMD can be that simple.

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