The efficient solution for Europe
FMD
Management
As a result of the EU FMD regulation, various alerts are created due to the detection of falsified packs or due to procedural or technical errors. The management of these FMD alerts in high numbers is a significant challenge for NMVOs, OBPs, MAHs, NCAs and End Users.
Designed as a collaboration platform for all involved FMD stakeholders, NMVS Alerts supports the necessary escalation and alert investigation procedures.
In addition to the alerts database, stakeholders can ask for and exchange helpful information such as documents, photos or remarks. All activities are tracked through the entire alert investigation process using NMVS Alerts whilst the End User stays anonymous towards MAHs and OBPs.
Therefore, NMVS Alerts is the perfect platform to optimize alert handling and monitor processes.
NMVS Alerts is a very easy to use and cost efficient, cloud-based application.
Get a quick overview about the main information about our Alert Management System
Key Facts
CLOUD-BASED APPLICATION
It is not necessary to invest in IT infrastructure, servers, administrators, application support, etc..
The only things you need to work with NMVS Alerts are your computer, a browser application and an internet connection - that's all!
INTUITIVE HANDLING
NMVS Alerts is designed in such a way that handling is absolutely simple and intuitive.
No time-consuming and costly training courses are necessary and your work with NMVS Alerts can be started immediately.
HIGH-SECURE ENVIRONMENT
NMVS Alerts is hosted on the Microsoft Azure Cloud. We selected this professional cloud service to secure stability, continuity,
performance, scalability and the highest possible grade of security for our customers.
COVERS COMPLETE EUROPE
NMVS Alerts manages all of your alerts - across whole FMD Europe.
ALL IN ONE SYSTEM
Focus on your FMD alert resolution processes in only one system! You do not need to change anymore between different applications, excel files, or databases. All your daily work can be done only with NMVS Alerts.
SAVE TIME & MONEY
We optimized the handling in NMVS Alerts to save your time and money. Powerful functionality like bulk handling of alerts or the resolution on batch level gives you the chance to significantly reduce your effort and save money.
PROFESSIONAL SUPPORT
In case of questions or problems, our professional application support will be happy to assist you. Contact can be made via phone or email in English or German. We help directly so that you can be productive again.
EMVO AMS HUB CONNECTION
The EMVO AMS Hub will connect all European FMD stakeholders to the Alert Resolution Process. This integrated feature is already available without additional costs. NMVS Alerts passed EMVO's system qualification process.
Key Components
In order to best cover the numerous requirements of our customers, we have designed NMVS Alerts with
the following main benefits in mind:
ALERT MANAGEMENT
NMVS Alerts is a very powerful application which manages a high number of FMD Alerts in a very efficient way. The multi-user platform consolidates all alerts in one place and offers user-friendly filtering and sorting functionality.
A popular feature used by NMVOs and OBPs/MAHs is Batch Level Resolution – resolving alerts on a batch level enables significant effort and cost reduction for every stakeholder!
PROOF OF ACTION
All actions which are performed within NMVS Alerts during the resolution process of an alert are logged in the system, providing an audit trail for all stakeholders. This detailed information provides transparency for all investigation process participants. This Action Log can be used as a proof of action for National Medicines Verification Organisations (NMVOs) and National Competent Authorities (NCA).
COLLABORATION PLATFORM
Our application provides a platform to interact very easily with all participants of the FMD alert investigation process. All stakeholder communication can be take place directly in NMVS Alerts without the need to employ additional communication methods.
Documents and photos can be attached to an alert and exchanged between the stakeholders.
REPORTING
Integrated reporting functionality via Microsoft Power BI helps you to easily analyse and document your individual alert situation.
All time periods can be defined by the user for each report and reporting results are exportable as a basis for further analysis.
Stakeholders
The NMVS Alerts portal offers the functionality to collaborate and create maximum transparency on all FMD alerts. In addition to status and activities on a specific alert, further information like documents and images can be attached by the stakeholders throughout the investigation process to make alert handling efficient for all stakeholders involved!
We ensure that the End User stays anonymous towards MAHs and OBPs throughout the entire process.
All shown stakeholders below are part of the alert investigation process.
Product Lines
We would like to support all involved stakeholder groups in the FMD Alert Management Process.
Therefore we offer the following Product Lines of NMVS Alerts which cover the specific requirements of
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National Medicines Verification Organizations (NMVO)
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Onboarding Partners (OBP) and
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Marketing Authorization Holders (MAH)
Each Product Line provides the necessary powerful functional scope to reduce effort, time and costs.
To see more details, please click on the relevant product line below.
