The modern bioanalytical laboratory faces numerous challenges

Improving assay sensitivity, fast-tracking method development, increasing throughput, streamlining secure data transfer to and from LIMS, and simplifying data reporting. All of this must be accomplished in a secure and easy-to-use analytical environment.

The Waters Regulated Bioanalysis System Solution enables the bioanalyst to combine workflow-driven analysis and compliant-ready data acquisition, management, and reporting with best-in-class sample preparation, UPLC, and tandem quadrupole MS. It’s the world’s first platform to deliver the ultimate performance for bioanalytical laboratories today, as it prepares your laboratory to evolve with the next frontier in bioanalytical sciences.

The bioanalytical laboratory is facing some of the greatest challenges in the pharmaceutical industry. Increasing demands for more sensitive assays as well as faster turnaround of study information can seem at odds with the need to meet the complex and rigorous regulatory guidelines, such as assay validation, incurred sample reanalysis (ISR), metabolites in safety testing (MIST), and compliance.

At the core of the bioanalytical challenge is the need to acquire, process, and report data in a 21 CFR Part 11 compliant environment. This requires an analytical system that meets performance demands, fits in with laboratory workflow and practices, is flexible enough to evolve as technology advances – yet is still compliant and secure.

To date, the bioanalyst has addressed these problems by building their own system comprised of the best available components from different manufacturers. While this may have delivered the required level of assay sensitivity and performance, it has resulted in significant workflow, troubleshooting, system qualification, and software validation challenges. This compromise-based approach makes it difficult to manage change control and lacks flexibility to evolve and adopt new technology.

The Waters Regulated Bioanalysis System Solution, built upon the UNIFI Scientific Information System, meets the converging needs of investigators, analysts, managers, and QA and IT professionals by uniting best-in-class sample preparation, UPLC/MS technology, software, and support services in a single platform purpose-built for quantitative bioanalysis.

The platform integrates into the workflow of the bioanalytical laboratory in a secure and compliant manner, and enables better decision making within the drug development lifecycle of a pharmaceutical organization and its respective partners.

Learn more about this revolutionary platform from Waters at www.waters.com/bioanalysis