Alert Management

Suspected Falsification

General Errors

medAspis Messages​

Alert Management

Undo attempted by different user.

Error messages relating to incorrect reactivation only result in the matter being referred to the relevant regulatory authorities in the case of cross-market transactions (packs from another country).

Description and cause:

This error code indicates that a deactivation that was not carried out by the user is to be reversed. However, deactivations can only be reversed by the same organisation that carried out the initial deactivation.

Handling instructions:

If the batch originates from abroad, it must be set aside and must not be placed on the market until the cause of the fault has been identified.

Procedures for the scanning staff: ​

  • Are any other packs in the consignment or storage bay also affected?

Procedures for the responsible person:​

  • If the pack was delivered in a deactivated state, only the supplier can reactivate it. This must be done within 10 days, so please act promptly.

Further use of the pack ​

PLEASE NOTE! A pack that has already been deactivated by another organisation is not fit for distribution. Any subsequent point in the pharmaceutical supply chain will receive the same error message and refuse your delivery.

Special case: returns. If the pack is returned, the person in charge may apply simplified quarantine rules, for example, authorising the pack for immediate destruction.

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Support

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support@medAspis.com

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Operations Service

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Alert handling instructions

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Error messages

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Validation toolkit

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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

  • Customers can use the medAspis repair service if an FMD Speed Scanner supplied by medAspis is damaged. During the warranty period, we provide a replacement device free of charge.
  • The option of a free repair during the warranty period, as well as any other warranty rights, remains unaffected.
  • The medAspis replacement device service applies only to handheld devices purchased under a medAspis contract, regardless of the warranty period.

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:

  • How many falsification alerts were triggered, which types, and over what period?
  • What compliance risks exist?
  • How can your internal workflows be optimised?

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

  • Alert Messages in english (Solidsoft)
  • Fejlmeddelelser på dansk
  • Chybová hlášení v češtině
  • Villuboð á íslensku

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.

Download Validation Toolkit