Waters New Software Delivers Lab-Centric Business Intelligence and Enables Confident Audit-Readiness

Rhea-AI Summary

Waters (NYSE: WAT) has announced waters_connect Data Intelligence software, a new cloud-based application designed to enhance laboratory data management and audit readiness. The software integrates with Waters Empower Chromatography Data System (CDS) to provide comprehensive business intelligence on chromatographic data. Key features include real-time audit response capabilities, risk visibility for regulatory compliance, and system suitability monitoring that could help prevent failures estimated to cost up to $600,000 annually. The software will be available for ordering in December 2024.

Positive

• New software solution addresses costly system suitability failures ($600,000 per year)
• Reduces audit preparation time from 2 days to real-time response
• Cloud-based platform enables remote data access and scalability
• Integration with existing Empower CDS eliminates need for costly external applications

Negative

• None.

Insights

Tech Expert

This new cloud-based software release represents a significant advancement in laboratory data management, particularly for regulated industries like pharmaceuticals. The solution addresses critical pain points around audit readiness and compliance, with potential cost savings of up to $600,000 annually just from preventing system suitability failures.

The integration with Waters' Empower CDS platform is particularly noteworthy as it eliminates the need for costly third-party integrations while providing real-time analytics and remote access capabilities. The software's ability to predict and prevent failures through trend analysis of method, column and instrument suitability data represents a shift from reactive to proactive laboratory management.

The reduction in audit response time from two days to real-time access could significantly impact operational efficiency and regulatory compliance. However, success will depend on adoption rates and the software's ability to deliver on its promised seamless integration with existing Empower systems.

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 /PRNewswire/ -- 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.

waters_connect Data Intelligence software provides laboratories with comprehensive business intelligence on chromatographic data.

"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

• Learn more at waters_connect Data Intelligence
• Link to the product brochure and infographic
• Follow and connect with Waters via LinkedIn, Twitter, and Facebook

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.

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SOURCE Waters Corporation

FAQ

When will Waters (WAT) launch its waters_connect Data Intelligence software?

Waters will make waters_connect Data Intelligence software available for ordering in December 2024.

How much can Waters (WAT) Data Intelligence software save laboratories in system suitability failures?

The software can help prevent system suitability failures that cost pharmaceutical laboratories an estimated $600,000 annually, based on two failures per month.

What is the main benefit of Waters (WAT) new Data Intelligence software for audit preparation?

The software reduces audit preparation time from an average of two days to real-time response capability, eliminating manual data consolidation and potential analysis errors.