Waters Enhances Alliance iS HPLC System Software, Setting a New Standard for End-to-End Traceability and Data Integrity

News Summary

• Industry-first smart HPLC system to provide authenticated user access verification on onboard touchscreen for superior security.
• Integration of Alliance iS HPLC System with Empower Software ensures user actions are identifiable and auditable.
• Minimizes common user errors by up to 40% and enhances audit readiness by providing end-to-end traceability and data integrity.

BRUGES, Belgium and MILFORD, Mass., June 17, 2025 /PRNewswire/ -- 54th International Symposium on High-Performance Liquid Phase Separations and Related Techniques - Waters Corporation (NYSE: WAT) today announced the release of the Alliance iS HPLC System Software version 2.0, a significant advancement that delivers comprehensive, end-to-end traceability and enhanced data security for the pharmaceutical industry. Bringing the same secure architecture synonymous with Empower Software to the Alliance iS HPLC System touchscreen will enhance compliant monitoring and intuitive traceability for customers. Globally, more than 80% of novel drugs have been submitted to regulatory authorities using Empower Software.¹

With this release, the Alliance iS HPLC System delivers leading touchscreen security by offering individual and identifiable access control with user authentication. This innovation further reinforces the system's position as the most intelligent HPLC available today, setting a new benchmark for traceability while enhancing troubleshooting and operational efficiency. It ensures uncompromised data integrity from sample to result.

"Traceability plays an important role in the security and integrity of pharmaceutical data, and the FDA considers the absence of records to be highly significant when data discrepancies are observed," said James Hallam, Vice President, Liquid Chromatography-Mass Spectrometry, Waters Corporation. "Regulators expect to see full audit trails for human interaction with data and systems, and the integration of Empower Software user access control with the Alliance iS HPLC System sets a new standard for end-to-end traceability and data integrity in the QC laboratory."