DIGITAL TRANSFORMATION IN PHARMACEUTICALS

Digital transformation is something almost every company on the planet is already pursuing, as it transports them to the present and brings them closer to the future. Without a doubt, today, it is a necessity rather than a luxury. In this sense, and although the industrial sector has myriad ramifications, today, we want to talk about the digitization of industrial processes in the pharmaceutical sector.

The pharmaceutical industry needs the security and integrity of the data generated to be maintained throughout all stages of production. For this reason, the digitization of industrial processes in the pharmaceutical sector has peculiarities that must be respected. This industry requires production speeds as new diseases continue to emerge. As a result, new medicines have to be mass-produced. Efficiency and productivity are two of the objectives pursued through the digitization of the sector.

What is Pharma 4.0?

When we talk about Pharma 4.0 (a term coined by the International Society for Pharmaceutical Engineering), we are referring to the framework for adopting (and adapting) digitization strategies in the unique context of pharmaceutical manufacturing. In practical terms, Pharma 4.0 translates into increased connectivity within the manufacturing plant and between the various sites of the pharmaceutical company.

As mentioned, the paradigm shift that Pharma 4.0 brings to the pharmaceutical sector is not only in the production field but also involves the sectors of research, development, and distribution. A holistic approach relies heavily on tools such as big data, artificial intelligence algorithms, collaborative robotics, and cloud-based distributed architectures. In this scenario, communication systems play a crucial role in disseminating information inside and outside the plant.

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Conditions for the digitization of industrial processes in the pharmaceutical sector

As mentioned, the digital maturity of the pharmaceutical sector is also known as Pharma 4.0, and to achieve this point, we need to perform digitization of the process. It is, therefore, essential to identify the processes most susceptible to change and include them as priorities in the digitization plan. The digital transformation significantly improves the plant's production and automation systems and its R&D and commercial management activities. These are the requirements needed to deploy the scan process.

  • Perform an internal audit
    To implement the digitization of industrial processes in the pharmaceutical sector, it is essential to conduct an audit to conclude whether the company is ready to start the process. This step discusses all the technologies available and the tools you work with. Information is gathered to determine the project's scope and the time required to complete it. In addition, the digital knowledge of personnel is analyzed to determine if training is required. It is about setting realistic but ambitious goals. It would help if you usually worked with experts who are connoisseurs of digital transformation.
  • Communicate the process to all staff
    For the company's digitization to work, the entire team needs to be kept informed of exactly what will be done. This includes senior management and all personnel professionals. Communication must be fluid, as it will be much easier to digitize the organization if everyone is part of the radical change it will undergo. In this sense, the digital transformation process must not be perceived as intrusive but compatible with established work routines. It should be remembered that the goal of digitization is to save time and increase productivity, so this philosophy must be maintained right from the start of the process.
  • Set specific goals
    The digitization of industrial processes in the pharmaceutical sector can only be successful if concrete goals are set right from the start. It makes no sense to transform the company without a goal, as this process involves effort, time, and money. It will be worth it as long as you get what was proposed. If this condition is met, the changes made will last much longer.
  • Focus on management
    One of the main reasons processes digitized is to improve the company's management in every way. It's not just about automating tasks; this transformation should help optimize the management of the professional organization's information, production processes, and activities. Also, try to access plant data easily.
  • Design a scan plan
    Digital transformation depends on many factors, so it is necessary to design a rigorous scanning plan that contemplates all the characteristics and needs of the company. The plan should include long-, medium- and short-term actions to ensure its impermeability in the face of unforeseen events and thus ensure success. The plan's design should also consider the estimated expenses generated by digitization and the potential economic benefits that will be realized at its expense, as well as operational efficiency improvements, cost reductions, and concrete improvements in production quality.

Challenges to be faced in the digitization of industrial processes in the pharmaceutical sector

While industrial digital transformation can make it much easier to manage the production and operations of a pharmaceutical plant, it is essential to always keep in mind that several challenges must be addressed.

  • Data Integrity
    The so-called data integrity refers to all this information relating to the composition and production of medicines, as this is a very delicate and strictly controlled process. Digitization is necessary to complete information, but it's a problem that will always exist in this area. Every movement and modification made to the machinery responsible for producing products in this sector must be recorded and stored to demonstrate that strict and safe standards are complied with.
  • Accessibility of medicines
    Drugs are expensive goods to produce and, therefore, expensive to obtain. For this reason, it is essential to implement the digitization of industrial processes in the pharmaceutical sector since greater accessibility to these products can be achieved if higher productivity and efficiency increase. Digital transformation is the first step towards achieving this goal, which benefits society.
  • Adaptation to new technologies
    Many new technological resources, such as big data analytics, are already well-established. However, there is still a long way to go in integrating systems based on artificial intelligence or virtual reality application in the pharmaceutical sector. Innovation will be vital in reaching new health milestones, so this industry will always need to be alert and willing to adapt to constant change.

The benefits of digital transformation in pharmaceutical companies

Digital transformation is changing the Pharma world, and excellent opportunities are opening up for companies operating in the sector. Digital transformation is now also taking place in the pharmaceutical world. The so-called Pharma 4.0 operating model adapts strategies and digital elements to the complex and highly regulated pharmaceutical industry.

Its realization involves various aspects within companies, ranging from processes to human resources, from work organization to the general mindset. By exploiting the potential of digital as much as possible, healthcare companies aim to provide innovative solutions to improve people's well-being.

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The importance of digital transformation for pharmaceutical companies

"Digital transformation in Pharma affects aspects such as research, production, and distribution but also internal processes and workflows, as well as the relationship methods between these companies and their public, i.e., patients and healthcare professionals," explains Alessia Sersanti, Co-Founder, Managing Partner and Marketing Director of Polk&Union, a digital communication agency with solid experience in the pharma sector.

According to the manager, "digital transformation offers four significant advantages to pharmaceutical companies, which can also be found in marketing and communication.

  • First, it increases efficiency: digital technologies such as AI, automation, and big data can help streamline and speed up decision-making processes in various areas thanks to more agile and dynamic structures, platforms, and teams.
  • Secondly, it allows you to exploit data-driven insights: having large amounts of data under control is another benefit of digital transformation. Thanks to the monitoring of the information collected and organized, it is, in fact, possible to define more specific strategies.
  • Again, improve target audience definition and engagement: Identifying and engaging your target audience is essential. Digitization and digital marketing tools make it possible to define the target better and involve them with valuable and personalized messages and content.
  • Finally, it enhances internal communication and digital skills: with digitization, it is possible to unleash the enormous potential in work topics, in each department, by improving communication and operations".

Conclusion

The concepts related to 'pharma 4.0' are making their way into the world of drug manufacturers. This industry model's unique characteristics drive investments in digital transformation; this is also due to the particular delicate historical moment. A trend that certainly didn't start today but which, in this unexpected and complicated period, has seen an unprecedented acceleration.

On the one hand, the sector is subjected to significant stress; on the other, it is faced with unprecedented opportunities. However, this is an acceleration that will continue after the expiration of the urgency. Therefore, the digitization process in the pharmaceutical sector must look at the present and medium-long term.

For the pharmaceutical world, this can translate into a coherent combination of interventions in different fields.

  • In production, for example, systems for optimizing the yield of a production line based on advanced data analysis.
  • In quality, considering systems for identifying and correcting deviations based on artificial intelligence.
  • Logistics, which includes solutions to ensure transparency along the entire supply chain.

Furthermore, the working context of companies operating in the pharmaceutical and medical sector is characterized by multiple regulatory requirements: industry standards, binding standards, and strict legal regulations that greatly influence quality management and process documentation, as well as the administrative burden that as a result, there is a strong impact in terms of costs and efficiency.

The solutions proposed by Setec help to meet these stringent requirements, including.

  • The archiving and administration of the most relevant documents, such as standardized operating procedures, work instructions, or forms
  • Optimized management of training courses to certify the documents subject to training and entered into force
  • Assistance in the drafting of applicable documents using a personalized mark (watermark)
  • Accurate traceability of the life cycles of essential documents
  • Extensive integration of third-party systems such as ERP systems (SAP, Microsoft Dynamics NAV, abas ERP, etc.), merchandise management systems (including WinLine), but also self-developed systems
  • Automated archiving of invoices and process-related communication thanks to convenient invoice and e-mail management.

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