Accelerating innovation without losing sight of compliance
The Life Sciences sector in Belgium is undergoing rapid change. Innovations in data and AI-offer new opportunities, but also present complex challenges, particularly in a highly regulated environment such as Life Sciences. Mats Govaerts, AI Lead Life Sciences and IT Compliance Consultant at Sopra Steria, finds himself right at the intersection of technology, regulation and innovation. We spoke with him about the nature of his work and the developments shaping his field.
A dual role
His role is twofold, explains Mats. “On the one hand, I work as an IT Compliance Consultant. This means helping pharmaceutical companies comply with regulations such as 21 CFR Part 11 from the Food and Drug Administration (FDA), EU GMP Annex 11 and the GAMP 5 Guidelines. We translate that legislation into operational processes.” This involves activities such as drafting procedures, validating computerised systems and setting up governance structures.
At the same time, as AI Lead, he is responsible for devising, implementing and overseeing Sopra Steria’s AI strategy within the Life Sciences market. “For example, we have developed several AI solutions that are currently undergoing validation for deployment within GxP-regulated environments. I lead these projects and support the adoption of AI solutions for the Life Sciences sector across our organisation.”
Entrepreneurship
Interestingly, Mats did not start his career in IT. “No, I trained as a laboratory technician. While working for a biotechnology company, I realised just how much data was available and how many opportunities it presented. That motivated me to retrain in bioinformatics and data science. My interest in AI arose when the first publicly available large language models (LLMs) became accessible. I started experimenting with them straight away.”
He has now been with Sopra Steria for around three years. He is currently engaged with several clients, including Curium, a producer of radiopharmaceuticals for diagnostic and therapeutic applications in nuclear medicine. “There, we work at a global level and contribute strategically. For example, I helped set up the governance framework for IT-compliance and data integrity.”
What particularly appeals to him about Sopra Steria is the freedom to develop himself, explore new ideas, and demonstrate entrepreneurship. “I have genuinely been able to do that here. I started as an IT Compliance Consultant and was then given the opportunity to help build AI within the Life Sciences market. Out of pure interest, I launched an AI-community, which over time evolved into an AI Competence Centre and has now become part of our market strategy.”
Assessments
A significant part of Mats’ work involves conducting assessments. “We analyse a client’s current processes and compare them against applicable regulations and industry requirements. Based on this, we advise where improvements are needed.”
He also advises organisations in harmonising processes following mergers and acquisitions. “The pharmaceutical industry sees a great deal of acquisition activity. Following an acquisition, companies often end up operating sites in several countries, each with its own way of working. We offer support to harmonise the different working methods and bring them together within a single, consistent structure.”
Developing an AI-tool for audit trail reviews
Alongside projects of this kind, Mats is involved in developing innovative solutions within Sopra Steria itself. One project he is particularly proud of is the development of an AI-powered tool for audit trail reviews. “An audit trail records data changes, actions and workflows in a chronological and tamper-evident manner. It allows organisations to determine who changed what, when and why data has been changed. Audit trail reviews are among the most time-consuming data integrity activities in many organisations. They are a regulatory requirement, but reviewing them is often highly manual and labour-intensive. By applying AI, we automate and speed up this process and reduce human error.”
At the same time, his team is developing a broader validation approach for AI systems, enabling organisations to deploy them in a compliant manner. “If all goes according to plan, we hope to go live with this during the summer.”
Challenges
It is precisely at the intersection of innovation and regulation that the sector’s greatest challenges emerge. “The biggest challenge facing the industry is striking the right balance between speed, innovation and compliance,” says Mats. “Pharmaceutical companies want to accelerate digitalisation and deply new technologies such as cloud solutions and AI. However, every change must be documented, validated and fully aligned with regulatory requirements. This makes innovation more complex than in many other sectors. The challenge becomes even greater with AI, where technology is evolving at an extraordinary pace while organisations must simultaneously consider governance, validation and responsible use within GxP-regulated processes.”
Within this landscape, Sopra Steria plays a broad and strategic role. “Our strength lies in combining deep expertise in Life Sciences regulations with the ability to implement digital solutions effectively. We not only understand how emerging technologies such as AI work, but also how to deploy them compliantly within a GxP-regulated environment,” says Mats.
“We can support clients throughout the entire journey, from strategy and governance to implementation, validation and operational support. This includes establishing quality management systems, supporting organisations during audits and developing tailored solutions. We even conduct mock audits, simulating official inspections to ensure clients are fully prepared.”
AI is playing an increasingly significant role within the Life Sciences sector. “We are seeing AI being applied more widely, for example to automate repetitive tasks such as audit trail reviews, the drafting of compliance documentation and the development of AI validation frameworks,” says Mats. “In addition, there is a clear shift towards cloud adoption and digitalisation. We are also seeing growing interest in Computer Software Assurance (CSA), where validation efforts are aligned with the level of risk to patient safety and product quality, placing greater emphasis on critical thinking and effective control mechanisms.”
Safeguarding patient safety
What makes his work particularly rewarding is the combination of technology, regulation and real-world impact. “Ultimately, the work we do in computerised system validation is about safeguarding patient safety. At the same time, you are given the freedom to develop ideas and grow professionally. When I joined Sopra Steria, I had relatively limited experience as a consultant, but I was given the opportunity to set up an AI-community, transform it into an AI Competence Centre and, today, I’m sitting at the table helping to shape the strategy.”