Development by SoftGroup AD of a prototype of innovative service SoftGroup® SaTT Cloud, acting as a link between client systems and state-regulated data repositories

The main idea of this project is to develop and test a prototype of an innovative solution on the European market for high-level socialization as a service that we can validate and demonstrate in a relevant environment. We will call this solution SoftGroup® SaTT Cloud. The prototype of the innovative service that will be developed and tested under the project is a cloud solution that will act as a link between client systems and state-regulated repositories (hubs). It is planned, as a result of the project's implementation, to reach a technological readiness level TRL 7 - system prototype demonstration in operational environment. The software product innovation developed under this project is in response to the requirements of: • Directive 2011/62/EU (amending Directive 2001/83/EC) relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, introduces a requirement that each individual carton must have a unique identification number (serial number) and • Commission Delegated Regulation (EU) 2016/161 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use. In view of the aforementioned directives, introducing the requirement for all European manufacturers of medicinal products to implement a system through which each carton gets its own unique serial number by the beginning of 2019, the targeted market niche of software solutions for serialization and traceability of medicinal products has a huge potential for development. Considering the essence of the product innovation developed under the project, the project is entirely focused on the field of “ICT and Informatics” by ISIS, priority axis “Big Data, Grid and Cloud Technologies“.

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