News Summary:

  • waters_connect™ Data Intelligence software provides laboratories with comprehensive business intelligence on their chromatographic data throughout the product development lifecycle, enabling real-time audit readiness and query response, while reducing time spent on audit preparation.



  • Cloud-based software proactively provides visibility into risks that could trigger adverse regulatory findings, delivering seamless remote data access, comprehensive analytics, historical trends, scalability, and cost efficiency.



  • Provides actionable insights from Waters™ Empower™ CDS software to help prevent system suitability failures, that can cost up to $600,000 per year.i

MILFORD, Mass., Nov. 7, 2024 -- Waters Corporation (NYSE: WAT) today announced waters_connect Data Intelligence software, a new cloud-based application that helps customers in regulated industries improve how they access, organize, analyze, and drive productivity from laboratory information. The software leverages data from Waters Empower Chromatography Data System (CDS) enabling laboratories to achieve confident audit-readiness, helping laboratory managers respond more quickly to audit inquiries with insights, and making informed decisions faster.

"Organizations need to ensure there are no missteps with data quality and integrity to avoid product release delays and failed quality regulatory audits that can cost tens of millions of dollars and delay lifesaving treatments," said Dave Leitham, Vice President, Connected Science at Waters Corporation. "waters_connect Data Intelligence software provides organizations with a new level of transparency into their data, making it easier to analyze and deliver valuable operational and scientific insights in real time, thus enhancing readiness for business-critical audits."

Designed to work with Empower CDS, waters_connect Data Intelligence software generates in-depth, configurable dashboards that deliver advanced analytical insights on laboratory data such as aborted injections and sample sets to help reduce the risks associated with adverse findings in regulatory audits. Where users of Empower CDS can take, on average, two days to respond to an auditor's question,ii they can instead avoid costly manual data consolidation and interpretation that could lead to data analysis errors.

waters_connect Data Intelligence software is designed to work seamlessly with Empower today and in the future, eliminating costly integrations to homegrown or external applications. It provides real-time remote data access, seamless tracking of long-term trends and patterns, and always reflects the latest data from any Empower-connected instrument. The software enables trending of method, column, and instrument suitability data, which helps preempt failures before they happen. The annual cost of system suitability failures in pharma laboratories is estimated to be $600,000 based on two failures per month.

"From the early demos and usage of the new software, we really like the flexibility that the waters_connect Data Intelligence tool offers for tracking system usage, column shelf-life, and user utilization," said Donny Preiss, Associate Director, IT Lab Applications at biopharmaceutical company, MannKind Corporation. "The new software will allow for streamlined processes in our laboratory, more meaningful data usage, and quicker business decisions." 

waters_connect Data Intelligence software can be tailored to organizations with single or multiple Empower CDS instances and is available for demonstration and quoting now, and to order in December 2024.

Additional Resources

About Waters Corporation (www.waters.com)

Waters Corporation (NYSE:WAT), a global leader in analytical instruments and software, has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, food, and environmental sciences for more than 65 years. With approximately 7,500 employees worldwide, Waters operates directly in 35 countries, including 14 manufacturing facilities, and with products available in more than 100 countries.

Waters, waters_connect, and Empower are trademarks of Waters Technologies Corporation.

Contact:

Janice Foley

Senior Public Relations Manager, Corporate Communications

Waters Corporation

janice_foley@waters.com

+1.617.823.5555

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i Based on an average cost of $25,000 per failure, including a batch release delay of 48 hours for a typical small molecule drug, according to data acquired from a cohort of 19 customers during Waters User Executive studies. As an illustrative example of two system suitability failures per month, the average annual cost can be $600,000.



ii Based on Waters internal analysis and estimates.

 

Waters Corporation

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