U.S. Food and Drug Administration Expands Deployment of Waters Corporation Software to Support its Medical Products Testing Labs

News Summary:

• The U.S. FDA is expanding its use of Waters’ compliant-ready Empower Chromatography Data Software (CDS) and has added NuGenesis Laboratory Management Software (LMS) to support its medical products testing labs.
• Will provide common data management platform for five U.S. field labs performing pharmaceuticals analysis using a variety of measurement technologies.
• Transition to electronic records management system will speed data retrieval, automate essential audit and archival functions, and ensure compliance with legislative mandates.

Waters Corporation (NYSE: WAT) today announced the U.S. Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA) has purchased Waters™ Empower™ Chromatography Data Software (CDS) and NuGenesis™ Laboratory Management Software (LMS), expanding its deployment of Waters’ software to support its medical products testing operations across its five field science laboratories.

Both Waters software applications will provide the ORA labs a common platform for acquiring, processing, reporting, and archiving analytical data from a variety of measurement instruments. Transitioning to a fully-electronic, common data management strategy will also help ORA’s laboratories realize greater operational efficiencies and bring them closer to compliance with the Paperwork Reduction Act of 1995 and the National Archives and Records Administration stated goals of phasing out paper records beginning in 2022.

“We’re extremely grateful to the FDA for putting its trust in Waters’ Empower and NuGenesis software, expanding the capabilities of its labs to centrally capture, retrieve and secure vital data for nationwide testing of medical products in the United States,” said Dr. Udit Batra, President and CEO, Waters Corporation. “Since we commercialized Empower software 25 years ago, it has become the choice of numerous regulatory agencies and thousands of scientific organizations worldwide. Regulatory agencies like the FDA rely on the integrity and traceability of their lab data to help make vital decisions about the safety, purity and efficacy of drug products to help protect public health.”

In addition to supplying the software, Waters will install the computer hardware, assist with instrument qualification and software validation and train site analysts on the operation, configuration, and expansion of the data management system.

ORA is the lead office for all FDA field activities. Its laboratories inspect drug manufacturers, conduct sample analyses of regulated drug products and review imported pharmaceuticals offered for entry into the United States. The laboratories also perform a variety of chemical and materials analyses including high performance liquid chromatography (HPLC) and UltraPerformance Liquid Chromatography (UPLC™), mass spectrometry, nuclear magnetic resonance (NMR) imaging, spectroscopy, and thermal analysis.

The Waters Empower CDS is the world’s leading chromatography software platform with more than 250,000 licenses in use today. The enterprise version of Empower software controls and collects gas and liquid chromatography data from a variety of instrumentation brands throughout a laboratory and is a platform for assembling, reviewing, approving, and publishing data in various reporting formats. The Waters NuGenesis LMS links many types of laboratory data to the business operations of the enterprise with functionality such as sample submission, results review, stability testing, scientific search, multi-vendor software connection, laboratory inventories, data retention and legal hold, and laboratory execution methods.

Both Waters Empower CDS and NuGenesis LMS are available from Waters separately or as fully integrated software applications.

Additional Resources:

• Learn more about Empower Chromatography Data System software
• Get helpful tips and how-to’s using Empower by reading the Waters Empower Tip of the Week blog series
• Learn more about the NuGenesis Lab Management System
• Learn more about Waters Empower LMS integrating both Empower and NuGenesis software

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, and food sciences for more than 60 years. With more than 7,400 employees worldwide, Waters operates directly in 35 countries, including 14 manufacturing facilities, and with products available in more than 100 countries.

Waters, UPLC, Empower and NuGenesis are trademarks of Waters Corporation.

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“We’re extremely grateful to the FDA for putting its trust in Waters’ Empower and NuGenesis software ... " - Dr. Udit Batra, President and CEO, Waters Corporation