The medAspis Lean FMD system is largely maintenance-free.
Depending on your country’s Blueprint provider (Arvato, SolidSoft or securPharm), access certificates must be renewed at irregular intervals. Users can usually perform this task themselves with ease.
New versions of the software on the FMD Speed Scanners can either be downloaded fully automatically or manually controlled.
From time to time, the access certificates must be renewed.
The procedures differ depending on the Blueprint provider:
securPharm:
The renewal of your certificate is requested via the NGDA portal. You will then receive a letter from the NGDA containing a TAN that you can now use in your medAspis Control Panel. The required field can be found in the menu in the Control Panel under the securPharm Access tab.
Click on “Download certificate” to open a window in which you will be asked for your NID (establishment number, beginning with APO) and a one-time password. Please enter the password you received from the NGDA and click OK. The certificate is uploaded automatically.
“Save” the changes and the new certificate is activated and connected to your account.
Manual download of the certificate
If you have already downloaded the certificate (.p12 file) via the NGDA portal, you can also include it directly as a file in your ControlPanel.
To do this, please click on the green “+” symbol under ControlPanel/securPharm Access, “search” your PC for the certificate and enter the certificate password in the “Private Key Password” column. The column “Public Key Token” should remain empty.
“Save” the changes and the new certificate is activated and connected to your account.
You must request a new certificate from your NMVO. In the example presented here, this is SEVeM, the Spanish NMVO. In this case, the response is a user name, a TAN code and a URL.
From now on, the process continues in the medAspis Control Panel. Please go to the Account tab in the menu. From now on, the process continues in the medAspis Control Panel. Please go to the Account tab in the menu. Ensure that the fields under “Certificate” are populated with your valid Client ID and Client Secret (your NMVS credentials). Please click “Update certificate”
In the following window, enter the TAN received earlier in the process and click on “OK”.
Please do not forget to complete the process by pressing the “SAVE” button at the top of the screen. You have now set up your new certificate.
Our support team is always there for you.
Please use a larger screen to view the full support menu.
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.
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.
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.
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.
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.
Download the error messages directly to your computer in your local language.
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.
medAspis stands for proven quality and traceable processes. Lean FMD provides the necessary framework for this.
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.
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.