FDA Purchases Software from Waters to Support its Medical Testing Labs

The U.S. Food and Drug Administration ’s ( FDA ) Office of Regulatory Affairs (ORA) has purchased Waters Corporation’s 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.

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