Digital transformation is happening in all industries, including the pharmaceutical sector. The use of digital tools for business process optimization (BPO) can bring improvements to key performance indicators, cost-effectiveness, speed of development and production, and customer satisfaction. Process improvements can also help avoid errors and facilitate regulatory compliance.
Business process optimization and digital transformation in the pharmaceutical industry
Business process optimization (BPO) through the use of digital tools is a common trend in all modern industries. The pharmaceutical industry is no different and perhaps there is even more value in optimizing business processes in this area than in many others. It is a highly competitive environment, so a competitive advantage must be gained against other players. This can be attained either through innovation or through lowering costs. Business operations in this industry also require a highly skilled workforce, which is expensive and often hard to find.
One way many businesses in the pharmaceutical industry have been seeking financial savings is through outsourcing business processes, which is expected to become an $800+ billion industry by 2030. However, seeking savings through outsourcing business processes in the pharmaceutical sector is not always optimal or possible, not least because it is a heavily regulated industry. Thus, business process optimization through digital means might be a better option.
Digital transformation and compliance
The high degree of regulation is in itself a good reason to implement a process optimization project. Compliance with GMP (Good Manufacturing Practice) is very important in the pharmaceutical industry and can be facilitated through digital means. For instance, regulatory bodies require a consistent, well maintained, and accessible trail of documentation registering every step in the production and development processes. Documentation and general process optimization is also necessary to obtain certification, such as ISO quality management certificates. Document circulation, consistency, and storage can be vastly improved through the use of digital tools.
In the Polish context, the relevant regulatory framework is the Integrated System for Monitoring Trade in Medical Products (Zintegrowany System Monitorowania Obrotu Produktami Leczniczymi, ZSMOPL), which allows for sales of drugs to be monitored at both the wholesale and retail levels and for information to be transmitted to the relevant institutions in digital form. The main objective of ZSMOPL is business process optimization in the field of drug sales. Reporting through the platform has been a requirement since 2019.
Speed and efficiency
The Covid-19 pandemic has also exposed the need to increase efficiency and speed in all core processes, such as research, development, and production. Digital transformation, including business process optimization, can be a way to “speed things up.” This can apply to both production processes and general management, as well as R&D and clinical trials. In the latter case, digital transformation can not only help optimize business processes and lead to faster processing of data, but also improve the quality of results, potentially increasing the chances of approval for a drug, as well as bringing improvements in customer satisfaction. Digital tools can also help prevent medicine counterfeiting.
The goal of “speeding things up” may be at odds with traditional application development processes, which can take a lot of time. One popular approach to rapid application development (RAD) is to use no-code platforms, but they might not be sufficient in the highly regulated environment of the pharma industry or for precise solutions.
This is where low-code development might be used, as it combines the advantages of no-code development (RAD and accessibility to experts in other fields, who are not necessarily programmers) with the ability to design highly specialized and precise functionalities. The use of low-code platforms for digital process optimization has the advantage of being fast and accessible while allowing for the use of custom code, e.g., for creating a user interface or database.
These advantages are especially important for enterprise clients, where you need to build flexible and cost-effective solutions that match the specific context of the company. Low-code platforms allow you to start fast, while custom code makes it possible to adjust the system to the requirements or add functionalities that are not available with a low-code solution, e.g., a UI or a specific type of storage.
Other technologies that we have found useful in such cases include .NET and Azure, which are good for corporate class systems, because major companies often already use Microsoft’s technology stack.
Business process optimization—use cases
A digital business process optimization project can take on many forms, so let us take a look at some possible ways business processes may be improved through the use of digital tools, based on our experience.
Document management to ensure compliance with GMP standards
GMP compliance is crucial in the pharmaceutical industry because of the high risks associated with mistakes and because it is often required by regulatory bodies. With digital tools, the quality control department can easily ensure and monitor compliance of the workplace instructions with good manufacturing practices. They also ensure high quality, as every employee always has up-to-date workplace instructions. The document management process becomes streamlined and highly automated. This also reduces the risk of errors, thanks to advanced mechanisms ensuring that documents are correct and have been reviewed and accepted.
We have built such a document management system using the K2 low-code platform, .NET, and Angular.
Business operations—monitoring trade in medical products
The purpose of business process optimization might also be to ensure compliance with state regulations regarding sending reports on trade in medical products, such as is required by the Polish Integrated System for Monitoring Trade in Medical Products (Zintegrowany System Monitorowania Obrotu Produktami Leczniczymi, ZSMOPL). As mentioned before, this is a digital platform through which all entities dealing in pharmaceutical products in Poland have to regularly report all trade.
We have designed and built a custom solution for reporting trade in medical products to the central system, using .NET, MS SQL Server, and Angular. It greatly reduced the need for manual labor, as it automatically validates and sends data. Crucially, it ensures that legal requirements are met over time, as the data format is adjusted to the changing requirements of the central system.
Business process optimization project—product development
Using a number of technologies, such as the K2 low-code platform, .NET, Angular, MS SQL Server, and Java, we have created a product development system for one of our clients. What has it achieved in terms of business process optimization? First, process optimization—the system ensures that all manufacturing stages are fulfilled, all stakeholders and decision makers are involved, and all the required documents are attached.
Improvements to process efficiency include shortened time-to-market, allowing a new or modified pharmaceutical product to be registered and released to the market faster. Second, the software allows for enhanced monitoring, as all elements related to the development of a new product (specification, documentation, project team, decision makers, registration procedure, packaging, etc.) are handled by one system.
Managing complaints related to pharmaceutical products
Another of our projects involved a complaints management system integrated with the client’s software, to ensure smooth data flow, and with the Kamsoft software used by pharmacies, which allows them to send complaints directly. The whole system is also compliant with the GAMP 5 (Good Automated Manufacturing Practice) requirements related to the validation of IT systems working in the area of pharmaceutical manufacturing. We used K2, .NET, and MS SQL Server in this project.
What are the benefits of such a business process optimization system? First, it ensures compliance with industry regulations—in Poland the complaint management process is regularly audited by the Chief Pharmaceutical Inspectorate—and with the GAMP 5 regulations. The system achieves the desired, positive results in an accurate, consistent, and repeatable manner.
Another benefit is streamlining of the current process. Complaints are handled faster, with due diligence and fewer mistakes, while staying connected with end clients (pharmacies and pharmaceutical wholesalers).
Ensuring marketing activities are compliant with internal regulations of the company
A pharmaceutical business is still a business and is involved in business operations. Thus, any process optimization plan should include typical tasks, such as marketing. However, it must be noted that pharmaceutical companies need to comply with regulations regarding this area of their operations as well, which means that they may require purposely built tools in a marketing process optimization effort.
The benefits of optimizing business operations in the field of marketing through digital transformation are threefold. First, it provides improved work efficiency. Time-consuming tasks are sped up and the amount of manual labor is considerably reduced. Second, it ensures internal and external compliance. Finally, it ensures better control over processes, as users can generate reports that make it possible to manage them better.
We have created a system to ensure compliance of marketing activities with internal regulations and their cost control, using K2, .NET, and Angular.
Managing financial documents to streamline daily operations
Another business process common to both pharmaceutical and other companies, where a process optimization effort through the use of software could bring a competitive advantage, is managing financial documents.
There are a few advantages to making improvements to existing processes through the use of software. The first is, as always, reduced manual labor. The document management processes can be streamlined and some financial settlements can be automated. The whole process is thus sped up, as the system tracks progress and sends notifications to responsible employees if any action is needed. Finally, digitizing the process allows for enhanced monitoring, as the system should allow the users to create reports and make sure no document or step in the process is missing.
We have completed a financial document management process optimization project using K2, .NET, Angular, and MS SQL Server.
Data management systems to streamline business processes reporting
The last of the core processes common to all businesses, where digital transformation may allow a company to streamline operations, is business reporting.
The benefits of digital business process improvement are twofold. First, data quality is ensured, as the system makes it possible to identify golden records, i.e., the correct data variants. Second, accurate reporting is also ensured because reports based on correct data are trustworthy. Accurate reporting is an important part of business process management and digitization can make for more efficient processes.
We have built a system to ensure accurate business reporting by identifying correct data using .NET, Angular, and Azure.
Business process optimization in the pharmaceutical industry–conclusion
Industry leaders will tell you that success requires continuous improvement. Inefficient processes must be replaced with either new processes or optimized processes.
Digital transformation is a road to process improvement, all the more valuable in a highly competitive and strongly regulated industry such as pharma. Maintaining consistent standards and thorough documentation of all processes is important both to gain a competitive advantage and to ensure compliance with regulatory bodies (such as the Polish ZSMOPL system) and GMP standards. Using digital tools to monitor trade in pharmaceuticals can greatly improve process efficiency and reduce costs and error rates.
Digital tools can also be used to create an optimized process of research and development. A digitized complaints process can have a direct impact on improved customer satisfaction and increased efficiency.