A New Era for Regulated Labs: AI/ML Innovation as a Real Laboratory Capability
Life sciences organizations are building the next generation of laboratory excellence and are poised for it to be more than just an idea. Over the years, we’ve heard aspirational concepts ranging from a paperless laboratory to Pharma 4.0. We’ve debated concepts and what might be possible someday.
The pace of artificial intelligence (AI) advancement has shifted what can be achieved, accelerating the ability to move past ideas to present reality. We are now in an era where technology, when executed well and in line with industry standards, can move an organization beyond simply generating quality data. The advanced automation achieved with AI creates a new level of consistency and trust in both data and decisions. The goals of speeding up medication delivery, flagging potential issues earlier, and advancing risk management and patient safety are no longer a future concept.
57% of CEOs believe insufficient AI explainability could trigger a customer trust or brand credibility crisis.1
Global AI Confessions Report: CEO Edition 2026
In our daily lives, we use AI for speed and convenience. But in regulated labs, the currency is trust. When deployed properly, AI can help eliminate human variability, deliver more consistent results, and build greater confidence in both the data and the decisions that follow. But proper deployment is more than just introducing new technology, it means ensuring AI is validated, operates consistently, meets industry and regulatory requirements, and produces results that can be relied upon. The future belongs to life science organizations that can successfully combine these benefits, improving efficiency without compromising trust.
Read our recent blog post to get a closer look at expectations for using AI in regulated labs.
The discussion is no longer hypothetical
Regulators have clearly outlined their expectations for the use of AI and machine learning (ML):
- Every action must operate within a framework of scientific rigor, compliance, and quality
- Context of use must be clear to ensure it is operated as intended
- AI must be explainable by the scientists who use it
- Every result must be traceable
- Every decision must be defensible by quality leaders
Waters has taken the leap to end the experimentation phase of AI/ML in a regulated laboratory.
85% of top 20 Big Pharma leaders view AI adoption as an immediate strategic priority.2
Define Ventures, Inside the C-Suite Report
For decades, Empower Chromatography Data System (CDS) has been the trusted backbone of labs where compliance and data integrity are non-negotiable. The success of an analytical lab has been defined by its ability to generate quality data–collecting, managing, protecting, and proving its integrity. Leveraged to standardize and optimize chromatographic workflows, Empower CDS has helped life sciences companies realize a myriad of efficiency gains over 30-plus years. Our Waters Informatics team has focused on where AI/ML could bring the next benefit to labs. The answer is data review and chromatographic peak integration.
AI is already demonstrating its potential to improve consistency and reduce human variability. A 2020 study published in Nature3 found that an AI system outperformed radiologists in breast cancer prediction for mammograms, reducing both false positives and false negatives.
In regulated labs, the same principle applied, AI must not only identify potential issues but do so reliably and within the required standards. Our first step was in 2025 with the introduction of AI/ML Anomaly Detection in Empower Data Viewer on the Waters Cloud Platform. By using machine learning to compare target results across chromatography data and expedite surfacing deviations for review, we are taking an important step towards bringing AI/ML directly into the analytical workflow. The capability is available in Empower Data Viewer today, with validated, compliant deployments to follow.
Our next step with Empower Software Solutions takes AI/ML a step further, providing a mechanism to consistently integrate chromatograms based on your definition of accurate data with machine learning. For a pilot study of 400 chromatograms, manual interventions dropped from 90 interventions to four after AI-powered peak integration was implemented.4 AI-powered peak integration increases the speed, consistency, and scalability of data processing, reducing the manual effort and variability that slow analytical labs without eroding productivity or confidence in results.
It is built for high-throughput, regulated labs and complements established Empower Software workflows. It will be available for early access in December 2026 while Waters works toward validated, compliant deployment.
From potential to reality and beyond
Waters is at the forefront of the shift toward cloud-enabled, AI/ML-driven laboratory informatics and is delivering on the promise of AI/ML with integrated, scalable capabilities inside established lab workflows, so you can realize the benefits of intelligent automation today, with Waters advancing these capabilities toward a validated, compliant deployment.
Empower Anomaly Detection and ML Peak Integration represent our ongoing commitment to deliver future-ready software solutions that adapt to changing regulations, innovations, and markets to improve outcomes for labs, particularly those in regulated environments. These innovative capabilities enable your organization to move from experimenting with AI/ML to using it for practical applications that improve the speed, trust, and scalability of data review and processing.
The benefits go beyond just access to new technology—it is unlocking the ability to perform data processing in new ways that were previously impractical or not possible.
Waters intends to continue expanding AI and machine learning functionality across its software platform. Waters goal is to make the compliant data foundation the trusted starting point as laboratories progress toward agent-driven and increasingly autonomous operations.
Learn more about how Empower Software Solutions deliver the compliant-ready results that your lab needs.
References
- Dataiku, Global AI Confessions Report: CEO Edition 2026
- Define Ventures, Inside the C-Suite Report, 2025
- https://www.nature.com/articles/s41586-019-1799-6
- Waters internal pilot study with a global pharmaceutical partner, 2025. Data on file, Waters Corporation
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