The world’s first compliant-ready system for regulated bioanalysis

To address the challenges of performance, sensitivity, flexibility, compliance, and productivity in the modern bioanalytical laboratory, Waters has created a new generation of system solutions. The Waters Regulated Bioanalysis System Solution is an application-focused platform that enables the bioanalyst to combine improved workflow-driven analysis, data acquisition, and reporting with best-in-class sample preparation, tandem quadrupole mass spectrometry, and UPLC®. All this is achieved with the next generation of compliant-ready software for GLP data acquisition and management.

The Waters Regulated Bioanalysis System Solution is driven by a novel user-focused, state-of-the-art scientific information management system that delivers an entirely new level of performance and security.

As the world of bioanalysis and DMPK continues to evolve, bioanalytical laboratories will face new challenges such as microsampling, dried sample spot analysis, and large molecule bioanalysis.

The new UNIFI-based bioanalytical platform from Waters is built with enhancements that anticipate the ever-changing needs of laboratories:

• Its architecture and unique Qualification Center enables a fast and structured approach to system qualification, which allows updated, upgraded, or new software and hardware technologies to be added without the need for wholesale revalidation.
•  Within this secure environment, calculations such as matrix effect, assay validation, and batch study summaries can be produced, following a simple, automated workflow-driven process. This enables you to meet the compliance levels and standards set forth by your organization and the productivity demands for your laboratory.
•  The platform’s intrinsic design facilitates data standardization so that information may be exchanged and shared among departments and third-party partners globally. It enables all laboratory functions to work with a common backbone of analytical information comprised of successful methods, processed results, and historical data and reports.

The Waters Regulated Bioanalysis System Solution, featuring Oasis and Ostro Sample Preparation Products, the ACQUITY UPLC I-Class System, the Xevo TQ-S Mass Spectrometer, and the novel UNIFI Scientific Information System, delivers the ultimate system performance for bioanalytical laboratories today, and prepares your laboratory to evolve in step with the next frontier in bioanalytical sciences.

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