Last week, I had the incredible opportunity to present on current trends in Health and Life Sciences (HLS) Automated Testing and facilitate a roundtable discussion with industry professionals, in collaboration with Tricentis. The event focused on Digital Validation and Artificial Intelligence (AI) and how these technologies are shaping the future of compliance, efficiency, and innovation in regulated environments.

With 18 professionals from 10 companies in attendance, we had engaging conversations about the challenges, opportunities, and real-world applications of AI and automation in the HLS sector. It was inspiring to see industry leaders share their insights on modernizing validation processes while navigating regulatory requirements.

Deep Dive: AI and Digital Validation Breakout Sessions

To explore these critical topics further, Nate Custer and I led two breakout sessions—one focused on AI and the other on Digital Validation. These sessions sparked discussions about the growing role of AI-driven automation, risk-based validation approaches, and compliance strategies.

One of the key takeaways was the increasing importance of modernizing compliance and validation processes. The industry is at a crossroads where organizations must balance innovation with regulatory obligations, ensuring both efficiency and adherence to evolving guidelines. Companies are actively seeking ways to optimize quality assurance, testing, and compliance workflows through automation and AI-driven methodologies.

The Industry’s Approach to CSA Adoption

A significant part of our discussion centered around Computer Software Assurance (CSA) and the various ways companies are navigating its adoption. We identified three distinct approaches:

1. The Cautious Approach: Some companies are choosing to wait until the FDA fully formalizes CSA guidance before making any changes. They see the status quo as the safest route, ensuring continued compliance without unnecessary risks.
2. The Investigative Approach: Others are actively researching CSA and gradually adopting a risk-based approach to quality. These organizations focus on high-risk areas first, testing CSA concepts on a smaller scale before implementing broader changes.
3. The Proactive Approach: The most forward-thinking companies are fully embracing CSA, investing heavily in automated and ad hoc testing while prioritizing high- and medium-risk activities to maximize efficiency and compliance benefits.

Each approach reflects a company’s risk tolerance and readiness for change. However, one thing was clear—CSA is paving the way for a more efficient, modern validation landscape in HLS. Organizations that take a proactive stance will likely gain a competitive advantage by streamlining their testing and validation processes while maintaining regulatory compliance.

How AI is Changing the Industry

Another key topic of discussion was the impact of AI on verification and validation. The conversation began with thought-provoking questions:

• What AI-driven tools are you using today for verification and validation?
• What AI-powered applications are you responsible for testing?
• What AI use cases feel especially exciting to see?

This discussion led to a deep dive into self-healing testing, a concept that leverages AI to automatically adjust and update test cases based on evolving requirements and system changes. Participants explored how AI can accelerate testing cycles, reduce manual intervention, and improve accuracy—ultimately leading to a more adaptive and efficient validation process.

Additionally, we explored how AI is being applied in predictive analytics, anomaly detection, and automated test generation. The potential for machine learning algorithms to identify trends, predict failures, and optimize validation efforts is an exciting frontier in HLS.

As AI adoption grows, companies will need to ensure proper governance and validation of AI-powered systems, particularly in regulated environments where patient safety and data integrity are paramount. This presents both opportunities and challenges, as organizations navigate how to best integrate AI into their existing compliance frameworks.

Moving Forward

As organizations continue refining their strategies, it’s clear that AI and automation are no longer just emerging trends—they are essential tools for modernizing validation and testing practices. Companies that proactively adopt these technologies will be better positioned to enhance quality, maintain compliance, and improve patient safety.

A huge thank you to all attendees and to Tricentis for partnering with us to make this event a success! The discussions reinforced the critical role of AI and digital validation in driving efficiency, compliance, and innovation in the HLS industry. Looking ahead, it will be exciting to see how AI-driven automation and digital validation continue to evolve.

Stay tuned for more Health and Life Sciences insights and takeaways from these groundbreaking discussions!