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

Rhea-AI Summary

Waters Corporation (NYSE: WAT) has announced Alliance iS HPLC System Software version 2.0, featuring enhanced security and traceability features for pharmaceutical industry applications. The update integrates with Empower Software, providing authenticated user access verification on the onboard touchscreen. Key improvements include individual access control, comprehensive audit trails, and up to 40% reduction in human errors. The system has earned ACT Ecolabels for sustainable practices and will be available from August 2025. Notably, over 80% of novel drugs have been submitted to regulatory authorities using Empower Software, highlighting its industry significance. The integration aims to enhance compliance monitoring and establish new standards for data integrity in QC laboratories.

Positive

• Integration with Empower Software enhances security and provides comprehensive audit trails
• Reduces human errors by up to 40% through system intelligence
• Earned ACT Ecolabels certification for sustainable manufacturing practices
• Strong market position with Empower Software used in 80% of novel drug submissions

Negative

• None.

Insights

Laboratory Technology Analyst

Waters' HPLC software update strengthens compliance capabilities, reducing errors by 40% and setting new security standards for pharmaceutical testing.

Waters Corporation has released a meaningful upgrade to its Alliance iS HPLC System Software, delivering enhanced security features that address critical pharmaceutical industry needs. The version 2.0 software integrates authenticated user access verification directly on the instrument's touchscreen, creating superior end-to-end traceability when combined with Waters' Empower Software - a platform already used in 80% of novel drug submissions to regulators.

This integration strategically positions Waters to capitalize on the heightened regulatory focus on data integrity. The FDA specifically flags missing records during data discrepancies as highly significant concerns. By reducing human errors by up to 40%, this system directly addresses a pain point for pharmaceutical quality control laboratories while minimizing compliance risks.

The competitive advantage here is substantial. Waters has effectively extended its industry-leading Empower compliance architecture to the instrument itself, creating a seamless audit trail that tracks all human interactions with both data and hardware. This addresses a specific regulatory expectation while simplifying laboratory workflows.

Waters has also secured ACT Ecolabels for this product line, highlighting sustainability credentials that increasingly factor into purchasing decisions. The August 2025 release timing gives the company an opportunity to impact Q3/Q4 sales cycles, particularly for pharmaceutical customers facing regulatory scrutiny around data integrity practices.

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."

The integration further enhances the simplicity of the Alliance iS HPLC System, which reduces human errors by up to 40% and enhances productivity in the QA/QC lab through innovative system intelligence that addresses errors before they can occur.²

In addition to its intuitive and secure design, the Alliance iS HPLC Platform has earned the Accountability, Consistency, and Transparency (ACT) Ecolabels from My Green Lab, a nonprofit organization dedicated to building a global culture of sustainability in science. The product line was recognized for its sustainable manufacturing practices and error-reducing capabilities, underscoring the Company's commitment to reducing environmental impacts.

Alliance iS HPLC System Software version 2.0 will be available from August 2025.

Additional Resources:

• Audit trail white paper
• Alliance iS HPLC Landing Page
• FDA Title 21 Chapter 1 Subchapter A part 11: FDA Title 21 Chapter 1 Subchapter A Part 11: Electronic Records, Electronic Signatures

Alliance and Empower are trademarks of Waters Technologies Corporation.

ABOUT: Waters Corporation (NYSE:WAT) is a global leader in analytical instruments, separations technologies, and software, serving the life, materials, food, and environmental sciences for over 65 years. Our Company helps ensure the efficacy of medicines, the safety of food and the purity of water, and the quality and sustainability of products used every day. In over 100 countries, our 7,600+ passionate employees collaborate with customers in laboratories, manufacturing sites, and hospitals to accelerate the benefits of pioneering science.

Contact:

Molly Gluck
Head of External Communications
Waters Corporation
Molly_Gluck@waters.com
Mobile: +1.617.833.8166

References

1. Presented at the J.P. Morgan 43rd Annual Healthcare Conference. According to internal analysis, ~80% of the drugs filed with the FDA, EMA, and China National Medical Products Administration (NMPA) in 2023 were done so using Empower Software. Source: Waters data and estimates.
2. Estimate based on Waters market research in 2022 after surveying 56 global pharmaceutical company QC labs.

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SOURCE Waters Corporation

FAQ

What are the key features of Waters Alliance iS HPLC System Software 2.0?

The key features include authenticated user access verification, integration with Empower Software, comprehensive audit trails, and up to 40% reduction in human errors through system intelligence.

When will Waters (WAT) release the Alliance iS HPLC System Software 2.0?

The Alliance iS HPLC System Software version 2.0 will be available from August 2025.

How does the Waters Alliance iS HPLC System improve data integrity?

It provides end-to-end traceability, authenticated user access control, comprehensive audit trails, and integration with Empower Software to ensure all user actions are identifiable and auditable.

What certifications has the Waters Alliance iS HPLC Platform received?

The platform has earned the Accountability, Consistency, and Transparency (ACT) Ecolabels from My Green Lab for its sustainable manufacturing practices.

What percentage of novel drugs use Waters' Empower Software for regulatory submissions?

More than 80% of novel drugs have been submitted to regulatory authorities using Empower Software.