Waters Introduces Regulated Bioanalysis System Solution Facilitating Consistent and Compliant Workflows

From Sample Preparation to Results, Regulated Bioanalysis System Solution Manages the Task of Obtaining Quantitative Bioanalytical Measurements Under G(x)P Requirements

The new Waters Regulated ioanalysis System Solution, a breakthrough LC/MS/MS system for bioanalysis that combines the latest in sample preparation, UltraPerformance LC (UPLC separations technology and chemistries, tandem quadrupole mass spectrometry, and the UNIFI™ Scientific Information System. This first-of-its-kind, single-vendor system solution is tailor-made for bioanalytical laboratories and generates quantitative results quickly and accurately, maximizes uptime, reduces cost per sample, and helps bring projects to completion more quickly.
Designed first and foremost with the needs of the bioanalytical scientist in mind, the Waters Regulated Bioanalysis System Solution ties together all the necessary components for streamlined bioanalysis of small molecule drugs and biotherapeutics.

Waters intends to ship the first units of the Regulated Bioanalysis System Solution with UNIFI in the fourth quarter of 2011.

From sample preparation to final report, the Regulated Bioanalysis System Solution includes:

• Oasis® and Ostro™ Sample Preparation Chemistries – delivers the cleanest extracts and minimizes matrix effects
• ACQUITY UPLC® I-Class System – Waters lowest dispersion and lowest carryover UPLC system delivers maximum separations power to ensure resolution from the matrix
• ACQUITY UPLC Columns – a broad range of chemistries to maximize selectivity
• Xevo®TQ-S – featuring unique off-axis ion source technology that delivers unprecedented levels of sensitivity and selectivity for the quantitation of trace levels of drugs and their metabolites in the most complex samples
• UNIFI Scientific Information Management System – represents a single platform for LC and MS operational control and for bioanalysis data processing, visualization, reporting and the configuring of G(x)P compliance tools such as electronic signatures and audit trails. Features embedded tools that simplify system qualification and software validation.
• Unique bioanalysis workflows with integrated tools such as RADAR that accelerate analytical methods development by giving scientists MRM and full scan MS data in one experiment
• Waters post-sale service and support expertise, including automated system qualification and validation services

Today’s bioanalysts must often piece together their own multi-vendor system which requires them to trade off data quality or productivity in order to meet regulatory requirements. The resulting compromises have prevented them from reaching their full potential.
“Managing a compliant bioanalytical laboratory often requires supreme effort to maintain a high level of efficiency and quality. For many laboratories, months spent validating methods and qualifying instrumentation and software is a fact of life,” says Gary Harland, Regulated Bioanalysis Program Manager, Waters Division. “We believe there is a better path to scientific and business results. With Waters Regulated Bioanalysis System Solution we’re giving bioanalysts what they have been asking for: the best possible analytical performance in an end-to-end system solution that allows scientists to carry out their experiments while maintaining the integrity and security of their results. For laboratory managers we’re giving them the ability to stay current with the latest in instrument and software technology and the ability to adapt as business needs grow and change.”

Waters Regulated Bioanalytical System Solution is powered by UNIFI – Waters next generation informatics software. UNIFI software is a one-of-kind single platform for controlling all LC and MS operations, processing LC and MS data, and generating IQ/OQ/PQ reports, maintaining electronic maintenance logs and signatures. Its user interface is available in multiple languages so that scientists can work with the software in their own language. And, it easily imports from and exports data to LIMS systems ensuring data integrity. UNIFI’s server based architecture enables workgroup deployment to maximize productivity and data integrity, while reducing validation overhead. The software features intuitive, streamlined and secure workflows specifically tailored for the bioanalyst.

Waters Regulated Bioanalytical System Solution brings laboratories these important benefits.

• Comprehensively meet the converging needs of scientists, analysts, managers, QA and IT professionals
• Measure matrix effects, identify and understand the impact of metabolites with the industry’s most sophisticated bioanalytical toolset
• Facilitates compliance with increasing regulatory demands, such as ISR, MIST, 21 CFR Part 11, and G(x)P
• Improved ability to adapt to changing scientific, business, regulatory, and industry challenges
• Develop robust methods faster with the sensitivity to meet assay requirements
• Maximize uptime and minimize cost per sample
• Improved ability to meet project deadlines; strengthen client relationships

For more information on Waters Regulated Bioanalysis System Solution, go to www.waters.com/bioanalysis.