Safe products are essential in the pharmaceutical industry – but what role does change control management play in this? Let’s take a closer look.
Summary: There is no doubt – we live in the digital age. Almost every industry has already embraced Digital Transformation. But what about the highly regulated pharmaceutical sector – is a digital path even possible here? In this article, we explore the opportunities and challenges of Digital Transformation in pharma’s strictly regulated environment and highlight the possibilities that arise when partnering with Yaveon.
It comes as no surprise that Digital Transformation is also reshaping the pharmaceutical industry. New technologies and digital opportunities create potential to optimize the entire lifecycle of pharmaceutical products. Today, many pharma companies are implementing digital data streams that extend across the entire value chain. This is often referred to as the “digital thread” – the continuous red line that connects different elements within the company, such as collaboration between humans and machines in a connected production environment or the integration of machine learning. The result: greater transparency across the entire organization.
It is clear that digital technologies are already influencing – and in some cases determining – the day-to-day business of the pharmaceutical sector. Yet many companies remain on hold, driven by a desire to preserve traditional practices or by concerns about meeting strict regulatory requirements. The risk? Falling behind competitors and only being able to meet current demands with significant additional effort.
When it comes to research and development, digital technologies offer enormous potential by enabling the processing of large volumes of data. They also simplify time-consuming tasks such as administration and data storage with automated workflows – making them faster and more accurate. The result: valuable insights that accelerate product development.
Another benefit comes from the use of digital twins. Computer-based models make it possible to simulate how active ingredients work, reducing the need for costly, time-intensive experiments. To identify and evaluate potential candidates, pharmaceutical companies also rely on virtual screening powered by databases, machine learning, and artificial intelligence.
Digital tools are transforming pharmaceutical production and logistics. Robotics can automate tablet pressing, while orders are managed digitally. Automated workflows save time, reduce errors, and help ensure consistent product quality.
Barcodes, RFID, and blockchain technology enable complete supply chain traceability, while track-and-trace systems help identify bottlenecks early and improve production conditions. Predictive analytics further supports process monitoring and optimization. Combined with the Internet of Things (IoT), which connects sensors and devices, the potential is vast.
Digitalization also creates new opportunities in patient management. Electronic records and the patient journey make treatments more personalized and precise. For pharma companies, this means the ability to develop more targeted products and deliver better results.
With electronic health records, information is stored centrally, enabling smoother collaboration across organizations. Health apps provide patients with new, easy-to-use treatment options – and often allow direct communication with healthcare professionals.
Clinical trials are critical for the pharmaceutical industry, but recruiting participants is often challenging. Digital platforms, including social media, make this easier, reaching a broader pool of potential candidates – so-called e-recruitment.
Once participants are enrolled, digitalization adds further value: electronic data capture systems store patient data centrally, making access and evaluation quick and seamless.
Automation is no longer optional in sales and marketing – it is essential. Digital platforms and customer journeys make it easier to target messages to the right audience. E-commerce and online sales channels also offer new opportunities, with greater reach and increased efficiency. The result: reduced workload and faster results.
Data lakes serve as massive storage systems, allowing companies to collect, store, and analyze data from a wide variety of sources. This enables integration with other solutions and creates a basis for innovation.
For pharma companies, this combination – often enhanced with AI – is especially valuable. Examples include identifying disease patterns, predicting drug effects, and enabling personalized treatments.
Access to data used to be limited to the office. Today, work takes place across multiple locations, teams, and organizations. Cloud solutions provide mobile access to data – anytime, anywhere – supporting collaboration across teams and partners.
Platform technologies make it possible to connect lab equipment, software, and databases. This improves data exchange and collaboration across the business. The result for pharma companies: more efficiency, precision, and innovation – benefiting everything from research and development to sales and patient management.
For companies aiming for long-term success, there is no way around digital solutions. Most pharmaceutical firms have already taken their first steps toward digitalization or converted key processes. Regardless of a company’s current level of digital maturity, the following reasons make a strong case for embracing Digital Transformation:
Digital solutions simplify the exchange of information and documents such as patient records – both internally and externally. Because data is stored electronically, it can be accessed securely, independent of location, and even on the go. Employees, partners, physicians, pharmacists, and patients can collaborate more efficiently. In short: digital technologies make communication easier, strengthen collaboration, and streamline information sharing. The result: faster decision-making and greater efficiency.
New players are entering the market, leveraging every digital opportunity – and quickly becoming competitors. To stay ahead tomorrow, companies must embrace change today. Digital solutions enable pharmaceutical businesses to react more agilely to market shifts. Compared to both new entrants and established rivals, pharma companies that embrace Digital Transformation are usually better positioned.
Digital processes save time. This not only benefits employees, who can focus on their core work, but also increases overall company output.
Digital Transformation supports pharmaceutical companies in research and development. Big data and artificial intelligence enable even vast data sets to be analyzed in a short time, generating actionable insights. Computer-based modeling and simulation make it possible to quickly assess whether drugs are effective and safe. The positive outcome: more innovation and new products, developed in less time and reaching the market faster.
Digital health records, personalized medicine, and virtual consultations make communication more targeted and meaningful. Patients often feel better understood – and satisfaction increases.
Data analytics, monitoring systems, and digital quality assurance tools support production processes. Faulty or defective products are identified earlier, and in the best case, issues can be addressed directly during production. The result: consistently higher product quality.
Digital tools assist physicians in diagnostics. Artificial intelligence plays a leading role here, enabling innovative, detailed imaging and analyzing results with high precision.
Is Pharma 4.0 already becoming a thing of the past? The future points toward Pharma 5.0 – the next stage of Digital Transformation in the pharmaceutical industry. Its focus: reshaping drug manufacturing in clean rooms, distribution, and usage. The goals are clear – more efficient production, higher quality, and stronger relationships between patients and pharmaceutical companies.
To achieve this, Pharma 5.0 leverages big data, artificial intelligence, and the power of cloud computing. Augmented reality and the Internet of Things (IoT) also play a central role.
Simply jumping into Digital Transformation? Not a good idea. To digitalize with focus – and achieve long-term success – companies need a well-thought-out digitalization strategy. This typically involves several key steps:
Digitalization only succeeds if it is embraced by the people involved. That’s why every digital initiative should start at the top. It is crucial that decision-makers stand behind the vision and actively support it. At the same time, all employees affected by the change should be involved from the outset – reducing misunderstandings and addressing concerns early on.
Where does the company stand from a digital perspective? This is a decisive question. In most cases, digital mechanisms are already in place and can serve as a foundation. At this stage, companies also identify the areas that will benefit most from Digital Transformation.
The next step is to clarify: What does the company want to achieve? Which goals are being pursued? Once these are defined, the focus shifts to how best to reach them. A digitalization strategy is created with clear milestones, covering all departments and aligned with the overall corporate strategy.
Now it’s time to create the necessary infrastructure – including cloud solutions, databases, analytics tools, and IoT devices. A key requirement here is ensuring seamless access to and exchange of data across systems.
Let’s go: company leadership prioritizes the first projects. These serve as reference initiatives on which further efforts can be built. Step by step, new approaches become embedded in the corporate mindset, supporting a structured digital rollout. Along the way, employees are gradually involved – and the first improvements provide extra motivation.
The idea matters – but acceptance matters even more. Automation and all its facets must become part of the company culture and be firmly established. Effective change management plays a key role here. It supports the transition to Digital Transformation by raising awareness, enhancing adaptability, and helping employees embrace new opportunities. Learning by doing, targeted training, and open communication all contribute to embedding the digital mindset.
Digital Transformation brings great opportunities – but it also comes with challenges. Typical hurdles faced by the pharmaceutical industry include:
Many companies moving toward process automation still start from heavily manual processes. Paper files here, loose documents there. The problem: without a consistent digital archive, data silos emerge. To fully leverage digital advantages, all data must first be collected and processed in a unified way.
For digitalization to deliver long-term and sustainable success, companies must stick to their defined approach. If management or key functions withdraw or refuse to adopt digital tools, gaps appear. The same happens when strategies are defined but not executed.
“We’ve always done it this way.” A phrase heard all too often in Digital Transformation – and one that blocks progress. Only those who remain open to change can successfully implement it.
Digitalization is closely tied to cloud solutions, which brings concerns about data security. This is a crucial issue – especially in the highly regulated pharmaceutical sector. Not every software solution meets strict data protection and regulatory requirements. The tightly controlled production of pharmaceuticals in cleanrooms, governed by GMP guidelines, must be prepared to comply.
The job market is changing. New roles are emerging alongside traditional ones. Employees need to acquire new skills and keep up with technological progress. At the same time, the industry faces a shortage of skilled workers. In many areas, resources are simply insufficient to handle the workload.
The solution that enables pharmaceutical companies to meet these challenges is software. But it is crucial to select a system that not only meets strict industry requirements but is also future-proof.
A proven option is an ERP system such as Microsoft Dynamics 365 Business Central. Designed specifically for the needs of mid-sized businesses, it is established, reliable, and continuously optimized. But is that enough for the pharmaceutical industry? The demands in pharma go far beyond standard functionality.
The answer: an industry-specific ERP extension that builds on Microsoft ERP – such as Yaveon 365. Our solution adds the capabilities that transform a strong ERP standard into a powerful specialist for the pharmaceutical sector.
Examples include:
Change control in the pharmaceutical industry – Beitrag öffnen
Safe products are essential in the pharmaceutical industry – but what role does change control management play in this? Let’s take a closer look.
The digital potential of the process industry – Beitrag öffnen
We show you how the process industry can discover and unleash its greatest digital potential.
Success story: Menicon – Beitrag öffnen
Menicon handles huge order volumes and product variants - read the full reference story now!
