WHO: Waters Corporation, Milford, Massachusetts, USA

WHAT: Waters Corporation (NYSE:WAT) has released the latest version of waters_connect™ for Quantitation 3.0 software to include capabilities to support pharmaceutical laboratories required to comply with regulatory standards and guidance.

waters_connect for Quantitation is a modern LC-MS/MS software solution for quantitative analysis, featuring a dynamic interface designed for effortless navigation throughout quantitative workflows. waters_connect for Quantitation is a combination of waters_connect, MS Quantitation, and the acquisition kit which includes sample submission, acquisition method editor, and its toolkit. It not only streamlines processes but also enhances laboratory productivity and enables data integrity.

The enhanced capabilities now expand Waters™ offering into regulated pharmaceutical environments, including Development, QC, and Manufacturing. The release of waters_connect for Quantitation equips organizations with the necessary tools to confidently support regulated LC-MS/MS workflows, ensuring data integrity and streamlining processes to enhance laboratory productivity.

These enhancements include:

• Comprehensive controls to enable 21 CFR Part 11 compliance, including restricted system access, a fully automated audit trail, and secure electronic signatures.
• Additional data integrity features to enable efficient, secure, and reliable access to all data and centralized data for connected LC-MS/MS and HRMS systems.
• Integrated calculations for genotoxic impurity analysis to automate the determination of impurity ppm levels in the Active Pharmaceutical Ingredient (API) and compare to regulatory Acceptable Intake (AI) thresholds.

WHY:    For pharmaceutical laboratories working to meet the regulatory and productivity demands of pre-clinical drug development through to manufacturing QC, the reliable generation of secure, traceable, and accurate quantitation data is crucial. waters_connect for Quantitation provides laboratories with the tools to help meet the required regulatory standards of analytical operation.

Designed to address the productivity and flexibility demands of modern analytical labs, waters_connect for Quantitation data integrity and compliance tools help enable you to comply with standards such as 21 CFR Part 11 and EU GMP Annex 11, which instils confidence in the data supporting your regulatory submissions and applications, while also facilitating streamlined analytical audits.

With end-to-end workflow support, centralized user, role, and configuration management, and the opportunity for connected LC-MS/MS and HRMS system networks, the software provides flexibility and enables collaboration and compliance across laboratories. The Exception Focused Review (XFR) functionality reduces data review times by up to 50%,^[i] allowing scientists to focus on critical insights and efficiently report back into development projects and manufacturing.

With an intuitive modern interface that streamlines new user onboarding, waters_connect for Quantitation enables efficient, high-quality LC-MS/MS data generation within regulated environments.

Additional Resources:

• Find out more at waters_connect for Quantitation

• Connect with Waters via Twitter, Facebook, and LinkedIn

ABOUT: 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 over 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.