Safe products are essential for the pharmaceutical industry. What is the role of change control in this? We explain.
Summary: There is no question that we are living in the digital age. There is probably no industry in which digitalization has not yet taken root. But what is the situation in the highly regulated pharmaceutical industry, is the digital path even possible here? We would like to dedicate this article to the opportunities and challenges of digitalization in the highly regulated environment of the pharmaceutical industry and show what opportunities arise from this in a project with Yaveon.
It should come as no surprise that digitalization is also having an impact on the pharmaceutical industry. New digital technologies and opportunities are creating potential for optimizing the entire life cycle of pharmaceutical products. Pharmaceutical companies are now able to implement digital data streams that extend along the entire value chain. This is referred to as the "digital thread", which links various contexts within the company, e.g. the cooperation between man and machine in the form of networked production and the embedding of machine learning. The result is increased transparency within the entire company.
It is clear that digital possibilities are having a far-reaching impact on everyday life in the pharmaceutical industry, and in some cases are already determining it. Nevertheless, many companies are in a waiting position, as the urge to preserve the tried and tested is too great or the concern of not sufficiently complying with regulations. The disadvantage: without keeping up with digital developments, there is a risk of being left behind and only being able to implement current requirements with considerable additional effort.
When it comes to research and development, digital technologies offer great potential by enabling the processing of large amounts of data. They also ensure that time-consuming tasks such as administration and data storage are completed faster and more accurately, for example through automated workflows. All of this serves to gain insights that are relevant for research and thus accelerates the development of new products. Another benefit results from the digital twin. This makes it possible to use computer-aided models to find out how active ingredients work. Traditional experiments, which are time-consuming and expensive, can thus be avoided. In order to identify and evaluate drug candidates, pharmaceutical companies also rely on virtual screening based on databases, machine learning and artificial intelligence.
Digital tools support the production and logistics of medicines: Robotics can be used to automatically press tablets and process purchase orders digitally. Automated work processes have the potential to save time, reduce errors and ensure or even increase the quality of your own products. Using barcodes, RFID or a blockchain, supply chains are also traceable and the traceability of products or product components is ensured. Such track-and-trace systems detect bottlenecks at an early stage and can improve production conditions. Predictive analytics helps to better monitor and optimize production processes. Combined with the possibilities of the Internet of Things (IoT), which integrates sensors and networked devices, there is a great deal of potential for the pharmaceutical industry.
Digitalization also holds new potential in patient management. Digital files, patient journeys and more ensure that pharmaceutical services reach patients in a more tailored way. Conversely, pharmaceutical companies are given the opportunity to create more specific products and thus advance their results and success. Thanks to electronic patient records, information is also stored centrally. A big plus for companies when it comes to smooth and comprehensive collaboration. Health apps that provide digital tips and application options represent new, uncomplicated treatment options, especially for patients. This is because it is often also possible to exchange information with medical professionals.
Clinical trials play a major role in the pharmaceutical industry. However, it is often difficult to find participants. This is easier via digital platforms such as social media, as companies can reach significantly more potential test subjects. We are talking about e-recruitment here. Once the people have been found, digitization has another advantage: electronic data collection using suitable digital recording systems for patient data. Access and storage are centralized, and evaluation is possible at the click of a mouse.
The automation of processes is not just a "can" for marketing and sales in any industry, but an absolute "must". Customer journeys and digital platforms make it easier to convey and present information to specific target groups. Potential can also be identified for e-commerce and online sales, as both areas can approach their target groups online and therefore with a very wide reach. Efficiency increases and less time is required.
Data lakes act as large data repositories for companies. This enables them to collect, store and analyze particularly large volumes of data from different sources. They also make it possible to merge data from different sources and integrate it into other solutions. Companies in the pharmaceutical industry benefit from this in particular, as they can use data analysis to react to unexpected and innovative developments. The possibilities of artificial intelligence are often used in the analysis. The combination? An optimal interplay. Examples include the identification of disease patterns, the ability to predict the effect of medicines and the personalized implementation of treatments.
In the past, access to data was usually only necessary from your own office. This has changed dramatically. Today, work not only increasingly takes place from several locations, but also involves different people or companies. Cloud solutions enable mobile access to data even when on the move and across different teams and contacts.
The use of platform technologies makes it possible to combine laboratory equipment, software and databases. This makes it easier to exchange data and optimizes collaboration. For the pharmaceutical industry, this results in greater efficiency, precision and innovation, as research and development, sales and patient management all benefit.
Companies that want to be successful in the long term cannot avoid digital solutions. Most pharmaceutical companies have already taken the first digital steps or have already converted relevant processes. Regardless of the company's level of digitalization, the following reasons speak in favour of going digital:
Digital solutions simplify the exchange of information and documents such as patient files - both internally and externally. The reason: electronically stored access with access data is possible regardless of location and on the move. Employees, partners, doctors, pharmacists and patients can exchange information more efficiently. Digital technologies therefore make it easier for employees and partners to communicate with each other, improve collaboration and facilitate the sharing of information. The result is obvious: faster decision-making processes and greater efficiency.
New companies that cover all digital possibilities are entering the market and often represent competition. If you want to be at the forefront tomorrow, you have to move with the times. Digital solutions make it possible to respond to market changes with greater agility. Pharmaceutical companies that make use of digitalization are usually better positioned compared to new and existing competitors.
Digital processes save time. This is not only pleasant for employees, as they can concentrate fully on their actual work, but can also increase the output of the entire company.
Digitalization supports pharmaceutical companies in the area of research and development. The use of big data and artificial intelligence ensures that even large amounts of data can be evaluated in a short time and the resulting analysis results can be used. Thanks to computer-aided modeling and simulation, it is possible to quickly find out whether and, if so, how effective and safe drugs are. The happy consequence of this is that more innovations and new products are developed in less time and reach the market faster.
Digital patient files, personalized medicine and virtual consultations facilitate exchange and create more targeted communication. In many cases, patients feel better understood and satisfaction increases.
Data analyses, monitoring systems and digital quality assurance tools support production. Faulty or defective products are detected earlier and, in the best case, direct intervention in the production process is possible. The quality of your own products increases.
Preventive diagnostics
Digital tools support doctors in diagnostics. Artificial intelligence is at the forefront in this area by enabling innovative, detailed imaging and evaluating it at the same time.
Will Pharma 4.0 soon be a thing of the past? The future is pointing towards Pharma 5.0, which encompasses the digital transformation of the pharmaceutical industry. Its focus is on changing the way medicines are manufactured in cleanrooms, distributed and used. The goal: more efficient production, higher quality and a better relationship between patients and pharmaceutical companies. To achieve this, Pharma 5.0 relies on big data and artificial intelligence and uses the possibilities of cloud computing. Augmented reality and the Internet of Things (IoT) play a key role in Pharma 5.0.
Data analysis and artificial intelligence generate more targeted treatment plans and tailor drug efficacy to individual patient needs.
The Internet of Things, artificial intelligence and cloud computing make it possible to digitally support drug production. Pharma 5.0 uses all of these technologies in a targeted manner to gain more and more targeted insights. The focus is also on process optimization and improved patient care.
The use of blockchain, i.e. a database that attaches more and more data blocks chronologically to an initial block of data, thus making every step traceable, and smart contracts, i.e. computer protocols for mapping contracts, make it easier for companies to develop new business models. These possibilities increase transparency in the pharmaceutical industry and improve cooperation.
Pharma 5.0 also aims to better network the various players in the healthcare sector and optimize the exchange of information. This will also enable teams to tackle complex tasks more easily and centrally.
The topics surrounding Pharma 5.0 focus on ethics and sustainability. Responsible, long-term production of medicines is the goal. Ecological, social and economic aspects are taken into account and guidelines on privacy and data protection are applied - particularly with regard to the handling of sensitive health data.
Just go ahead and digitize? Not a good idea. In order to digitize with determination and, above all, with long-term success, companies should rely on a well thought-out digitization strategy. This comprises several steps:
Digitalization is only successful if it is accepted by the people involved. The start of any digital project should therefore lie with the company management. It is extremely important that decision-makers are behind the idea and support the project. In addition, all employees who come into contact with the change should be involved from the outset in order to avoid misunderstandings and concerns.
Where does the company stand from a digital perspective? This question is crucial. In the vast majority of cases, there are already digital mechanisms in place that can be built upon. Possible areas that could particularly benefit from digitalization are also identified here.
The next question is: what does the company want to achieve, what goals are being pursued? Once these points have been clarified, the next step is to find out how best to achieve them. To this end, a digitalization strategy with defined milestones is defined that encompasses all departments and is in line with the overall corporate strategy.
The next step is to create the necessary infrastructure with which cloud solutions, databases and tools for data analysis as well as IoT devices can be put into use. It is important to ensure that data can be accessed and exchanged across all systems.
Let's go: Initial projects are prioritized by the company management. These serve as reference projects on which further projects are built. Step by step, the procedures can be integrated into the corporate philosophy. The digital rollout in the company is supported. In this way, employees are gradually involved and initial improvements provide additional motivation.
Yes, the idea counts. However, acceptance is at least as important. Automation with all its facets should become part of the corporate culture and be firmly anchored. Good change management processes help with this. Change management supports the transition to digital transformation by raising awareness of the need to perceive and implement change, increase adaptability and take advantage of new opportunities. Learning-by-doing, training, open communication - all of these help to consolidate the digital mindset.
Digitalization offers many opportunities. At the same time, however, it also presents companies with challenges. Typical hurdles that the pharmaceutical industry faces are
Companies striving to automate processes often start with highly manual processes. File folder here, document there. The problem: without a consistent digital filing system, data silos are created. In order to fully utilize the digital benefits, all data must first be collected and processed uniformly.
In order to be able to use digitalization and its possibilities successfully in the long term, the defined procedure should be followed through consistently. If management or key functions withdraw or refuse to use digital tools, this will result in gaps. The same effect occurs if the defined strategy is not implemented.
"But we've always done it this way." A typical phrase that is often heard in the course of digitalization - and is a hindrance. Only those who are open to change can implement it successfully.
Digitalization is closely linked to cloud solutions and concerns about data security. This is an important issue that must be taken into account - especially in the regulated environment of the pharmaceutical industry. After all, not all software meets the requirements of data security and authorities. The highly regulated production of pharmaceuticals in cleanrooms, which is subject to GMP regulations, must be prepared for this.
Personnel and resources
The labor market is changing. Existing job profiles are being joined by new ones. Employees have to learn new skills and move with the times. Another challenge is the shortage of skilled workers. There are not enough resources available in many areas of operation and the work that needs to be done cannot be fulfilled.
The solution with which companies in the pharmaceutical industry can meet these challenges is software. However, when researching, they should make sure that the solution meets their strict requirements and is future-proof.
An ERP system such as Microsoft Dynamics 365 Business Central is helpful because it is tried and tested, specially designed to meet the requirements of SMEs and is constantly being optimized. Is that enough for the pharmaceutical industry? The requirements in the pharmaceutical environment go beyond the standard functions. The solution: special industry-specific ERP software that extends the Microsoft ERP - like Yaveon 365. Our solution includes the functions that turn a good standard ERP into a specialist for your own industry.
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