How Chromatography Data Systems Are Shaping Modern Analytical Labs

Chromatography data systems simplify the way scientific data is collected, managed, and analyzed. They also help reduce errors by automating routine processes and keeping information consistent, which supports both daily work and regulatory requirements. With features for easy data access, sharing, and integration across different instruments, scientists can collaborate more effectively and make informed decisions faster.

To better understand these benefits and more, we recently spoke to Clarence Friedman, Portfolio Owner of Empower at Waters Corporation, who provided expert insights into how CDS tools are helping researchers save time, improve lab productivity, and ensure reliable results.

Biocompare: What role do chromatography data system platforms play in enabling high-throughput workflows, particularly as labs handle increasing sample volumes and complexity?

Clarence Friedman: Chromatography data system (CDS) platforms are often the workhorses of modern analytical laboratories—serving as foundational informatics systems that uphold data integrity, enable traceability, and support proactive decision-making. These capabilities are essential for implementing effective quality risk management (QRM). They play a pivotal role in enabling high-throughput workflows, especially as sample volumes and complexity continue to rise. Over the past decade, global pharmaceutical pipelines have nearly doubled—from approximately 12,000 molecules in 2015 to over 23,000 in 2025. At the same time, the proportion of complex biologics has grown from 30% to over 50%, demanding more sophisticated analytical capabilities. To meet these evolving demands, CDS platforms must deliver automation, enterprise scalability, and support for advanced detection techniques such as capillary electrophoresis, multi-angle light scattering (MALS), and mass spectrometry.

The most advanced CDS technologies will support centralized, cloud-based data access and management—and responsibly leverage AI to accelerate batch release and ensure therapeutic safety and efficacy.

BC: What are some best practices for ensuring data integrity and compliance when implementing or upgrading a CDS?

Clarence: Implementing or upgrading a CDS requires a risk-based approach aligned with global guidance such as ICH Q9(R1) and PIC/S PI 041-1, and compliance with regulations like FDA 21 CFR Part 11 and EMA Annex 11. Best practices include establishing strong data governance, mapping and validating workflows, and applying quality risk management principles. Using technical controls to design risk out of the system—such as minimizing human bias in integration decisions and enforcing least privilege access with clear segregation of duties—helps to reduce conflicts of interest and maintain audit readiness.

In the future of regulated laboratory environments, data integrity and compliance will be embedded and intrinsic—not just enforced. As labs scale globally and handle increasingly complex biologics and modalities, best practices will shift toward intelligent systems that reduce manual interventions, save analyst time, and minimize compliance risks from human error.

It is critical to advance CDS capabilities in a way that not only meets today’s regulatory expectations but anticipates tomorrow’s scientific and operational demands. CDS will evolve, equipping labs to move from reactive compliance to predictive, intelligent data stewardship.

BC: How do you anticipate future CDS developments will address challenges like data standardization and interoperability across different analytical instruments?

Clarence: As analytical labs tackle more complex modalities and data volumes grow, the ability to standardize and interconnect data across instruments is a necessity. Features such as multi-vendor instrument control and standardized data formats help labs reduce fragmentation and improve traceability. The future of CDS aligns with the FAIR data principles to ensure that scientific data is:

• Findable through rich metadata and centralized indexing
• Accessible via secure, scalable platforms
• Interoperable across diverse analytical techniques and vendor systems
• Reusable for downstream analysis, regulatory submissions, and intelligent insights.

We anticipate future CDS platforms will embrace open standards, semantic data models, and API-first architectures to enable seamless integration across chromatography, mass spectrometry, MALS, and other techniques. The CDS of the future must include technologies to support FAIR-aligned data ecosystems—where interoperability isn’t just about connectivity, but about enabling scientific collaboration, regulatory confidence, and accelerated innovation. Critically, these platforms must preserve complete data lineage, including metadata, method parameters, and audit trails, ensuring that every data point is traceable, contextualized, and ready for reuse across systems and workflows.

Biocompare: From your perspective, what trends in automation and AI are most likely to impact the way CDS platforms are used in analytical laboratories?

Clarence: Automation and AI are reshaping the role of CDS platforms—from passive data repositories to active decision-support systems. The next wave of innovation will go beyond streamlining routine tasks and ensuring compliance, to redefining how labs operate. Two major trends stand out:

• AI-driven processing: Machine learning will dramatically reduce the time spent on raw data analysis, peak selection, and integration—cutting hours down to minutes. This not only boosts efficiency but also reduces risk from human error with improved consistency across analysts and sites.
• AI-driven review: CDS platforms will evolve to support “review by exception” using AI to flag anomalies, trends, or compliance risks in data sets in real time, across labs, projects, and sites. This enables more focused and efficient decision-making, faster responses to risks, and reduces manual burden for QC teams.

Biocompare: How are chromatography data systems evolving to support integration with broader laboratory informatics platforms?

Clarence: CDS platforms are no longer just data acquisition tools—they are integration hubs at the heart of the digital lab, creating a unified, compliant environment where data flows securely and efficiently across the entire analytical ecosystem—to and from scientific data management systems (SDMS) and laboratory information management systems (LIMS). This evolution transforms CDS from a passive data repository into an active driver of scientific decisions, regulatory confidence, and operational efficiency, enabling data-driven decisions based on real-time analytical insights. Whether it triggers batch release workflows, flags out-of-spec results, or informs stability studies, CDS data becomes a strategic asset across the lab. The future of CDS lies in connected, FAIR-aligned, and intelligent architectures. These platforms will support global data harmonization, real-time collaboration, and intelligent automation. As labs face increasing complexity and regulatory scrutiny, integration is no longer optional—it’s foundational to enabling secure data sharing, scalable automation, and smarter science across every modality and geography.

Biocompare: What distinctive capabilities do Waters' CDS solutions bring to customers?

Clarence: Empower™ Software is trusted by thousands of laboratories worldwide because it delivers more than just chromatography, it delivers confidence. Approximately 80% of novel drug applications submitted to FDA are from organizations who leverage Empower™ CDS as the backbone of their laboratories. Its proven performance has been validated repeatedly in audits by regulatory agencies across the globe.

With Empower™ CDS, every aspect of chromatography data—from methods and raw data to results, metadata, and audit trails—is fully traceable. Compliance is not an add-on; it is embedded into the application, ensuring data integrity and audit readiness by design. Leveraging extensive technical controls, including a suite of privileges and tailorable calculations, Empower™ CDS minimizes risk across workflows to protect data and keep it under a state of control.

What truly sets Empower™ Software apart is data longevity. Our customers’ complete, original data is legible, enduring, and available for as long as it is needed—and carries over into platform version updates. This level of traceability is essential in today’s regulatory landscape. We have customers that have traced regulated data all the way back to the 1990s, ensuring full auditability and compliance across decades of CDS innovation.

Empower™ CDS is purpose-built to scale effortlessly, from a single workstation to global enterprise deployments, whether on-premises or in the cloud. Through Empower™ Software’s subscription model, customers gain access to cloud-native capabilities that expand automation, connectivity, and insight.