Compliance check-up:
Better safe than sorry
Better safe than sorry
Compliance check-up:
Better safe than sorry
Better safe than sorry
Companies in the pharmaceutical industry are validated and meet strict quality specifications. However, there is a considerable compliance risk around the topic of FMD: The suspected cases of counterfeiting that occur again and again in daily operations are not recognised, processed and documented in a GxP-compliant form.
With our free, anonymous and non-binding Compliance Check-up, we analyse and evaluate all critical alerts of your company. To let you know where you stand and how vulnerable you are.
By law (Delegated Regulation § 39), the authorities have the right to see all reports of potential falsification cases. For up to five years. In other words, not a single suspicion of falsification escapes the authorities. Upon request, you must be able to provide information about each individual case: What happened, how was the case handled?
With our cost-free Compliance Check-up, we conduct a comprehensive analysis of GxP compliance based on your existing FMD audit trail:
The analysis takes place entirely within your data system. So you don’t need to disclose any data. Everything remains anonymous.
Yes. We offer our Compliance Check-up to potential clients free of charge. On the one hand, we want to make you aware of potential risks. On the other hand, we would like you to get to know us: medAspis – The FMD Company. We can only do one thing. But that properly. FMD.
We work closely with all NMVOs and know the respective processes in the countries very well. And we are happy to support you in ensuring that FMD functions efficiently and in compliance with GxP.
Cost-free and non-binding FMD Compliance Check-up for GxP compliance.
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.