Robert Gaertner, Vice President of Quality Strategy Europe at Veeva Systems, discusses the growing importance of connected platforms in ensuring quality in pharmaceutical manufacturing and the shift toward personalized medicine.
Nowhere is quality more important than in healthcare. What challenges do biopharmas currently face in maintaining high quality?
There are many challenges in the pharmaceutical industry, and quality is a critical factor. Patients must trust that medicines are safe, meet high standards, and comply with regulations. With personalised medicine and other modern therapies, this becomes even more challenging. Unlike traditional medicines distributed through pharmacies, personalised therapies require extra layers of quality control. A good example is the public discussion around vaccines during the COVID-19 pandemic. People knew some vaccines had to be refrigerated, but they likely didn’t understand the extensive effort required. You can produce a high-quality medicine, but for it to remain safe and effective, you must monitor it until it reaches the patient. The more personalised the therapy, the more crucial this becomes.
How does Veeva help biopharmaceutical companies maintain quality?
There has been a significant shift in recent years. In the past, companies manufactured and tested medicines in-house. Now, manufacturers must pay more attention to the quality of their suppliers, and logistics plays a growing role as more of it is outsourced. While some companies specialise in logistics, the manufacturer remains responsible. This shift requires solutions that not only manage internal business processes but also integrate the entire supply chain, including partners. That’s why cloud-based, industry-specific solutions like Veeva Vault Quality have become critical. Cloud technologies play a key role in maintaining quality because companies need to communicate with suppliers and partners—and even patients—in real-time. This requires easily accessible, secure, and traceable data, all while staying compliant with regulations like GDPR.
Where do connected cloud platforms help the most, particularly with transparency?
Here’s an example: when a raw material is produced in another country, the quality decision requires approval based on the data the company receives. If this data is handled on paper, it causes delays. Connected cloud platforms provide real-time insights, and they ensure data integrity. With cloud solutions, everyone in the supply chain can access the same data simultaneously, reducing redundancies and improving decision-making.
How does Veeva help keep data entry clean and secure?
You have to look at the entire supply chain. In production, for example, some machines have sensors that provide data relevant for quality decisions. Another example is patient complaint management. If a patient experiences side effects, a doctor or healthcare professional enters this data manually. Ideally, they only need to enter it once, and the system ensures secure entry. Artificial intelligence can help ensure data is entered correctly, and quality checks can occur as soon as data is available. Connected cloud technologies, like those from Veeva, also bring together different data sources, whether from other digital systems or manual inputs, to maintain quality control.
Has Veeva developed a streamlined way to achieve this?
Yes. Veeva’s Quality applications are scalable and easy to access online. Companies can define which groups of people need convenient access to the database, and we can configure the system accordingly, always adhering to security requirements.
Looking to the future, what challenges could the industry better address in the next three to five years, possibly with AI?
There’s a constant tension between efficiency and compliance. Regulations must be met, but at what cost? The key for the pharmaceutical industry is balancing GxP compliance with streamlining quality systems to improve both cost-efficiency and quality outcomes. The focus should shift from managing quality issues to preventing them. AI can help predict potential risks and prevent them before they occur. Additionally, the definition of a pharmaceutical product will evolve. We often think of medicine as a pill or physical product, but future therapies will be more complex and personalised. Homecare and clinical trials are moving from hospitals to patients’ homes, where wearables will report data. This brings new quality challenges, such as qualifying devices and validating processes, which are easier to manage with cloud solutions.
What does the industry expect from Veeva in this regard?
We develop our solutions in collaboration with our customers. We aim to understand their challenges and work with our experts to develop innovative solutions that align with their needs. It’s a combination of customer input and our strategic vision, alongside regulatory requirements, particularly in the area of quality.
