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Pharmaceutical Industry review/Фармацевтична галузь, 2023, №5 (98) October

SoftGroup's cloud-based solution revolutionizes drug safety with serialization, aggregation and Track&Trace innovations

The technology has empowered us to gather, analyze, and manage immense volumes of data, leading to remarkable enhancements in the speed and precision of drug safety surveillance. Advancements in technology have revolutionized drug safety. This is very important in the context of Pharma 4.0.

What is Pharma 4.0 and how SoftGroup responds to the new tendencies in the industry?

Pharma 4.0 represents a digital framework tailored to the specifics of pharmaceutical manufacturing, drawing inspiration from the principles of Industry 4.0, the fourth industrial revolution characterized by the ascendancy of digital technologies and data. In the realm of Pharma 4.0, there is a continuous and proactive exchange of information and knowledge. This exchange occurs across the entire pharmaceutical supply chain, which includes both drug development and patient care.

Pharma 4.0 is a great way for pharmaceutical companies to achieve bigger transparency and quality while reducing overall costs.

Nowadays, is relevant to talk about not only for Industry 4.0 but also for Industry 5.0.

Industry 5.0 put the focus on humans and artificial intelligence working together. This collaboration inevitably will lead to a change in manufacturing. Certainly, this is an industrial revolution that will have a positive impact not only on the market, but also on the environment.

At present, Industry 5.0 is just starting to develop, and there is a lot of room for it to grow and improve in the future. SoftGroup is compliant with 5.0.

Among the company`s goals are to provide custom adapted-solution and secure communications.

Only companies that can adapt to these trends and capitalize on new opportunities will be successful in the rapidly evolving pharmaceutical landscape. Moreover, both Pharma 4.0 and Pharma 5.0 put the focus on sustainability in the pharmaceutical industry.

Who is SoftGroup?

As a global software company operating in the field of the Pharma industry, SoftGroup is a good example of a successfully modernizing structure, which follows the European and global tendencies for innovations and digitalization.

SoftGroup is helping the Pharmaceutical and MedTech industries transform their business, providing full-stack serialization and aggregation solutions.

In the last 20 years of experience, SoftGroup has been recognized as a reliable long-standing traceability partner from Big Pharma Leaders with many production lines to small Marketing Authorization Holders (MAHs) with no actual production.

What is SoftGroup Cloud-based solution?

The focus of the company is aimed at an end-to-end cloud-based solution. It is a comprehensive SaaS solution based on Microsoft Azure which resonates in SoftGroup`s way to follow the world`s new tendencies. The SoftGroup`s Cloud-based solution is the first choice for many pharmaceutical companies no matter of their size. This kind of Cloud-based are considered the future because they do not require a starting investment. Since it usually resides in a shared environment where the software license costs are low compared with the traditional model.

SoftGroup`s cloud solution ensures easier coordination among the counterparties within the business network. The company's SaaS solution resides in a Cloud environment that is scalable and integrates with other SaaS offerings. Its undeniable advantage is the fact that the data is secure in this cloud space and cannot be lost no matter what is happening in the real world.

Real People. Real Results.

How SoftGroup implements its Cloud-based solution in one of the top players in the CEE industry?

SoftGroup’s Client is widely regarded as one of the top industry players in the CEE region. The company operates worldwide including in the CIS region.

The Cloud-based solution is designed and fully adapted to the needs of all supply-chain participants (MAHs, Manufacturers, Importers, Wholesale trade enterprises, etc.)  and also to various pharma stakeholders with different sizes of production like the Big Pharma Leaders with many production lines, small Marketing Authorization Holders (MAHs) with no actual production, etc. in the pharmaceutical landscape across the CEE region.

The challenge

The pharmaceutical company was in search of an end-to-end solution that would enable them to handle serialization, aggregation, and Track & Trace tasks capabilities. The primary challenge was ensuring that they complied with current Track and Trace regulations without the need for costly and time-consuming adjustments due to future Regulatory changes.

SoftGroup's Client required an automated and secure system to efficiently manage their connections with various supply chain partners. They aimed to achieve this without making substantial additional IT investments.

The company also needed for secure, remote access to data of all its Customers' production facilities. This need prompted them to explore a more advanced solution for managing serialization data and generating reports. Moreover, this company’s partners’ requirements pushed it to look for a flexible aggregation solution (pallet aggregation) for the company’s different locations.

Solution selection

SoftGroup`s Client chose to work with company`s SaaS solution. This decision proved to be spot-on, primarily due to the platform's capability to be regularly updated to reflect ongoing regulatory changes and  ensure future-proof compliance with regulations, especially given the frequently changing Regulatory landscape in the CIS countries.

Furthermore, SoftGroup`s Client adopted the Cloud-based solution to effectively manage its IT department’s daunting task of managing communication with various supply chain partners, thus significantly improving the level of transparency and visibility between internal and external stakeholders. This automated communication provides a reliable connection that minimizes the risk of human error while also limiting the risk of data loss and corruption.

The fact is also the adoption of the cloud-based centralized management system that significantly improves its control and visibility of serialization data in each of its production plants.

Successful implementation

SoftGroup`s Client was able to implement a comprehensive Cloud-based solution which allowed the company to ensure high availability of its production and to benefit from maximum security and seamless scalability while avoiding any disruptions to its existing processes.

Now the company has a future-ready Cloud solution integrated into all of its production lines. It offers their QP seamless remote access and the secure review, publishing, and transfer of serialization and aggregation data between the company’s partners and the Regulatory Authorities.

SoftGroup provides service of Web Aggregation capabilities to the company’s operations which minimizes the investment needs towards new and complex aggregation equipment.

The capacity for aggregation of respective level addressed the company’s business partners’ requirements by introducing a more straightforward process of traceability starting from batch creation all the way to its reporting.

Microsoft Azure`s role

Hosted on the future-ready Microsoft Azure Cloud environment, the company`s SaaS solution provides premium reliability and performance metrics, scalability on demand, automatic data backup, secure identity, and access management, which pharmaceutical companies can rely on and benefit from.

The system's efficient and cost-effective business model enables each pharmaceutical company to streamline its processes by eliminating additional investment in expensive hardware and IT maintenance costs while benefiting from rapid deployment, advanced insights, and automatic updates.


In today's rapidly changing environment, pharmaceutical companies need to be highly adaptable, scalable, and flexible to succeed. The SoftGroup`s Cloud-based solution emerges as an excellent opportunity, especially for emerging markets like Ukraine and the CIS countries.

Success in these dynamic markets hinges on resilience and adaptability. As market landscapes shift, companies must adjust their strategies to remain competitive and relevant. Although the path to success may be challenging, these developing markets offer significant opportunities for growth and expansion.

In the ever-evolving pharmaceutical industry, embracing innovations like the SoftGroup`s Cloud solution is pivotal. This SaaS solution not only ensures the security and protection of data from hacking and abuses but also represents a smart business decision. It has already making waves in revolutionizing the pharmaceutical sector, opening doors to a brighter future.


Bulgaria, Sofia, 1766,
Business Park Sofia,
Phone:  +359 2 879 9577

Andrey Atanasov,
CRO/ Director Business Development & Sales



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