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Future-Proof Solutions for Regulated Laboratories in the Face of Changing USP <621> Guidelines

17 Sept 2018

This white paper discusses how to leverage the changing USP <621> guidelines with established methods, while providing options to immediately improve results and illustrate how to achieve long-term return on investment (ROI). By staying within allowable adjustments, significant benefits may be realized with only verification of the suitability of the method for its intended purpose, rather than a full revalidation.

Empower 3 Method Validation Manager (MVM)

Waters

Empower™ 3 Method Validation Manager (MVM), an option for Empower 3 Chromatography Software, allows you to perform chromatographic method validation, from protocol planning through final reporting, in one application.With Empower 3 MVM you can automatically: Manage method validation workflow in one comprehensive, automated application Clearly display the status of ongoing validation studies – enabling you to see at what step each individual validation parameter is in the method validation process Perform all result and statistical calculations in Empower 3, eliminating time-consuming data transfer to spreadsheets and the associated problems of transcription errors and security concerns Perform multi-component analyses and batch processing of method validation results Generate reports with standardized templates Empower 3 MVM provides a number of benefits to both the laboratory and organization, including: Cut method validation time and costs as much as 80% by eliminating manual steps in your current method validation process. Satisfy compliance requirements more easily while significantly improving data traceability. Eliminate the use of separate software applications during method validation. Automate, streamline, and simplify the method validation workflow. Easily determine if your data adheres to your method validation requirements and that your results are within specification. Store your method validation data securely and in one database.

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Waters Alliance™ HPLC System

Waters

An integrated HPLC system that works as hard as you do, available with push-button mass detection for the chromatographer. The Alliance™ HPLC System is the flexible and reliable workhorse that meets your fundamental HPLC separation requirements. The system has been continually expanded and perfected to accommodate an enormous range of real-world analytical challenges, culminating in today’s new industrial design which signifies Waters’ commitment to HPLC and our HPLC line. Today, users can extend the Alliance HPLC System’s performance with XP 2.5 µm Columns. XP Columns are compatible with both HPLC and UPLC technology and are designed to not only improve our HPLC productivity, but also facilitate a transfer to UPLC Technology platforms as well. Directly scalable between UPLC and HPLC particle sizes, these new 2.5 um XP Columns bridge the gap between HPLC and UPLC performance. Whether your lab analyzes samples in the pharmaceutical, chemical, food safety, environmental, or quality control arenas, the Alliance HPLC system offers you a field-proven solution. Integrated solvent and sample management to ensure consistent system-to-system performance and high reproducibility. Waters Alliance™ HPLC System Features: Full integration with either Empower® or MassLynx® Software for instrument control and data processing A large, intuitive LCD-based user interface allows rapid system set-up through SystemPREP routines that streamline daily start-ups Easy, tool-free maintenance resulting in maximized uptime Waters complete line of detection technologies – from routine UV/Vis detectors, to the ACQUITY QDa Detector to single, tandem and triple quadrupole mass spectrometers - extend your application capabilities

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Future-Proof Solutions for Regulated Laboratories in the Face of Changing USP <621> Guidelines