Level 4 Application

Microsoft Azure: The Cloud Solution trusted by European Authorities for Pharmaceutical Regulation

Franck Goron Written by Franck Goron
13/04/2017

Being the Cloud platform of choice for European authorities, Microsoft Azure will help pharmaceutical companies go beyond compliance.

There are not many options available in the market today for implementing a level 4/5 serialization solution. Many of the countries that will eventually require product data reporting to national or regional hubs don’t have a platform yet. This provides you with very few examples and best practices for your own compliance readiness.

Microsoft Azure and the European Medicines Verification System

One organization is however further along in the set-up of its data repository: In Europe, the Federation of Pharmaceutical Industries and Associations (EFPIA) has chosen to build the new European Medicines Verification System (EMVS) on the Microsoft Azure platform, in line with the Falsified Medicines Directive.

 

The Azure Cloud supports the full lifecycle of drug serialization data

Azure is the most unique and complete Cloud platform to support the full lifecycle of serialization data. The manufacturing and the pharmaceutical industries in particular are both highly regulated and need to handle large amounts of data travelling throughout the supply chain from product sourcing to consumers. The fact that the European Federation of Pharmaceutical Industries and Associations trusts Azure speaks volumes. Microsoft Azure provides a complete, scalable and secure Cloud platform to meet the demands of the pharmaceutical industry. It enables suppliers to plan, produce, deliver and comply while providing the opportunity to create safer and more cost-effective products.

Serialization is about Big Data

Serialization is first and foremost a Big Data project. A single pharmaceutical company usually handles hundreds of millions of serialized products every year, which means hundreds of millions of serial numbers, events to report and huge amounts of data to be securely stored and exchanged with authorities and supply chain partners or CMOs. Therefore, it was a logical step for Adents and Microsoft to join their respective expertise to develop Adents Prodigi based on the Azure Cloud.

Azure consists of a complete portfolio of secure, integrated and modular Cloud services that can be tailor-made to meet the key demands of the industry’s regulatory mandate along with Big Data management needs.

How does Azure consider the Pharma industry’s needs?

With Azure, Adents Prodigi offers many capabilities that enable the pharmaceutical industry to achieve their technical and business objectives.

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Data Security during Transport and at Rest:
During its lifecycle, serialization data is transported, saved, utilized and archived. Azure offers network security services along with the strongest available encryption algorithm and access rights management to ensure its protection. Only authorized parties with the appropriate access rights can manage information on the platform.

Isolation:
Azure services can be deployed in their own logical environment, completely independent from other services. The network they sit on can also be isolated to make sure that a given set of data belonging to an organization is managed by a dedicated network and set of services, never shared and never at risk of being exposed to unauthorized parties.

Scalability:
Azure resource management capabilities automatically provides additional resources (compute, memory, etc.) to services that need it and similarly, less resources when less are required. This feature has two main benefits. Firstly, it makes sure that an application like Adents Prodigi has access to the vast amount of resources available on Microsoft Azure. Secondly, it keeps the cost of managing data at its lowest by eliminating the need to pay for a large quantity of resources when they are not required.

Global Compliance:
Microsoft Azure Data Centers and services are certified to meet the strictest governmental and industry requirements (http://azure.microsoft.com/en-us/support/trust-center/compliance/). Data centers exist in many locations around the world (https://azure.microsoft.com/en-us/regions/) enabling applications deployed on Azure, such as Adents Prodigi, to comply with local and regional regulatory mandates.

Service Auditability:
Every layer of Microsoft Azure’s infrastructure contains logging capabilities which enable services like Adents Prodigi to capture every action taken by a user on the platform. Justification for data manipulation can also be captured and is archived to allow full traceability of usage on the platform.

Data Management Suite:
Managing data can take different forms and shapes based on the type of data you are manipulating, the volume of data, the frequency at which it is accessed, the performance expected, etc. The Azure data management service portfolio is one of the most complete on the market. From Big Data Management to traditional data warehousing and through high velocity data coming from the Internet of Things, Azure provides a choice of technology services that can coexist together within one application to offer the best possible architectural approach to manage your data effectively. No need to compromise and choose a “one size fits all” technology often limiting and increasing the cost of traditional data management. Azure Data Management capabilities also include Business Intelligence, Machine Learning and other Artificial Intelligence capabilities, key to the ability to automate the management of large amounts of data and generate the value business units expect from having this amount of data available.

Standard & Open:
Every application, especially when rooted into deep industry context (i.e. manufacturing or pharmaceutical) lives within an ecosystem of partner applications and organizations. Microsoft Azure leverages industry standards and open technology to guarantee that an application like Adents Prodigi will thrive within its ecosystem. Integration between services is enabled using common data formats (i.e. XML), common standards (i.e. GS1, EDI) and popular interface mechanisms such as RESTful API. Adents Prodigi has fully leveraged this capability and created a marketplace of partner applications that can be activated to leverage serialized data for creating new value added services (i.e. Global analysis of supplier’s performance).

Interoperability and connectivity with EMVS
Last but not least, one of the main advantages for the pharmaceutical industry is the fact that an Azure based serialization solution like Adents Prodigi will ensure easy connectivity with the European Medicines Verification System as it is developed on the same Cloud platform.

Beyond serialization compliance

It takes vision, experience and a deep understanding of the international pharmaceutical regulatory landscape to design an innovative solution that not only helps companies master serialization and data exchange regulations but allows them to enrich, analyze, and enhance their serialization data. With Adents Prodigi and the Microsoft Azure Cloud, you can go beyond compliance and turn your serialization data into business intelligence, all the while being compliant with serialization regulations as well as data security and protection regulations.

Learn more on this subject in our webinars

Franck Goron
Franck Goron

Franck is a Senior Digital Advisor at Microsoft, working with organizations to reimagine and transform their business models, operations, customer engagement and employee experiences, empowering them to reach their digital aspirations. Franck has 20 years of experience across the USA, Europe and Asia designing innovative enterprise solutions, developing business strategies and leading organizations in solving their most complex business challenges.

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