AI and Compliance in 2025: Predictions for Life Sciences

Introduction: 2025 and Beyond: The New Frontier for Compliance in Life Sciences

As we approach 2025, the life sciences sector stands on the brink of transformative change, driven by advancements in artificial intelligence. From enhanced anomaly detection to personalized AI assistants, the tools of today are paving the way for more efficient, scalable, and predictive compliance processes tomorrow.

Pharma IQ sat down with Doron Sitbon, Founder and CEO of Dot Compliance, to explore how these innovations are reshaping the industry and what the next few years hold. With predictions on AI’s evolution, regulatory challenges, and practical applications, Doron offers a glimpse into the future of compliance and quality management in life sciences.

The Evolution of Compliance Management

Pharma IQ: Doron, could you begin by sharing your background and how Dot Compliance came to be?

Doron Sitbon: Certainly. My journey began over 20 years ago as an industrial engineer specializing in information systems. I worked in early-stage AI at NICE Systems, exploring use cases like word spotting and emotion detection. About a decade ago, I started Dot Compliance to address the unique challenges of compliance and quality in the highly regulated life sciences sector.

Life sciences professionals have seen their roles evolve from acting as messengers in paper-driven processes to becoming air traffic controllers in modern digital workflows. But as data volume grows exponentially, the next transformation will see them becoming data analysts, drawing insights from vast and complex datasets to ensure safety, efficiency, and regulatory compliance.

Innovations Driving Immediate Impact

Pharma IQ: Let’s talk about your latest upgrades. Of the new tools—decision guidance, anomaly detection, and the personalised AI assistant—which do you think will have the most immediate impact?

Doron Sitbon: It’s not about a single "killer app" but rather an augmented set of capabilities—an "Ironman suit" for compliance professionals. These tools collectively enable faster data classification, trend analysis, and decision-making. For example, the anomaly detection tools help identify whether an issue is a recurring problem or a new one. At the same time, the personalised AI assistant transforms how teams access and utilize organizational knowledge. Together, they empower users to handle complex, dynamic environments with confidence.

The State of AI Adoption in Life Sciences

Pharma IQ: How would you describe the current state of AI adoption in life sciences, particularly in compliance and quality management?

Doron Sitbon: We’re still in the early adopter stage. AI today is more about augmentation than autonomy. Human supervision remains critical, ensuring AI tools enhance decision-making without replacing the human element. Over time, as trust and understanding of these tools grow, we’ll see broader adoption and more sophisticated use cases.

Overcoming Challenges in Regulatory Compliance

Pharma IQ: What challenges do companies face in adopting AI for compliance, and how can your solutions help?

Doron Sitbon: A key hurdle is the sheer volume of data points that need monitoring, from suppliers and manufacturing sites to patient-used devices. Our tools help connect these dots, providing a comprehensive picture of compliance risks. Another challenge is regulatory uncertainty, which varies across regions. For instance, the EU’s AI Act is setting new precedents, and we’re working closely with clients to navigate these emerging frameworks.

Looking Ahead to 2025 and Beyond

Pharma IQ: What’s your vision for life sciences and AI adoption in the near future?

Doron Sitbon: By 2025, I expect early adopters to be leveraging AI consistently for better decision-making. However, fully autonomous AI processes in life sciences are still a few years away. That said, the pace of technological advancement is extraordinary, and companies that embrace AI today will be better positioned to lead in this rapidly evolving landscape.

Conclusion: 2025: A Turning Point for AI in Compliance

As the life sciences sector enters 2025, it is clear that AI will play a critical role in transforming compliance and quality management. Doron Sitbon’s insights highlight the sector’s evolution from early AI adoption to a future where augmented intelligence enhances decision-making at every level. While fully autonomous AI processes remain a vision for the future, the strides being made today are setting the foundation for significant advancements in the years to come.

For companies ready to embrace this change, the time to act is now. As Doron points out, those who adopt AI thoughtfully and strategically will be best positioned to thrive in this era of unprecedented technological and regulatory transformation.