USDM

Chromatography data acquisition systems handle the widest variety of separation techniques such as GC, LC, LC/MS, CE and CE/MS to ensure fast and flexible data acquisition, complemented by advanced data analysis and reporting capabilities for highest productivity.

USDM provides a comprehensive solution to support Life Sciences companies in regulatory requirements for managing laboratory chromatography data. Our Validation Accelerator Package (VAP) provides validation assistance with core regulatory requirements for the following Perkin-Elmer TotalChrom functionality:

• Control of LC, GC, CE, CE/MS and LC/MS instruments and generic A/D converters as well as third-party LC detectors
• Chromatographic data acquisition, peak processing and calculations
• Central management of data, master methods and sequence templates.
• Simultaneous data acquisition from multiple chromatographs each with multiple detectors
• Database storage and retrieval of chromatographic files
• Internal and external standard calculation methods, calibration of group peaks and reference peaks
• User set parameters for peak display and specification for axes
• Seamless integration in non-regulated or highly-regulated workflows, including support for 21 CFR Part 11

USDM's Perkin-Elmer TotalChrom  VAP documentation provides a pre-configured content rich set of templates, ready for customization to meet both domestic and international regulations. Our documentation templates include:

• Validation Plan
• User Requirements Template
• Risk Assessment
• Functional and Design Specification
• Installation Qualification
• Operational Qualification
• Performance Qualification Template
• Trace Matrix
• Validation Summary Report

USDM works closely with PerkinElmer TotalChrom to identify upcoming patches and updates, and provides a full maintenance program for our Perkin-Elmer TotalChrom VAP clients. Impact assessment and recommendations for required testing are made to ensure our clients an effective, efficient process for maintaining a validated state of compliance.

Equipped with over 10 years of experience and specialization in regulated business processes, our skilled team of PerkinElmer TotalChrom validation professionals can provide your organization with innovative and streamlined alternatives to industry standards.

USDM has been successful across many Perkin-Elmer TotalChrom validation projects around the globe and our best-in-class validation services coupled with proven and effective methodologies can give your organization the competitive advantage it needs to thrive in today's regulated environment.

To learn more about USDM and how we can assist with your compliance and business objectives, please contact:

Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
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"Simplify, Unify and Optimize your business & compliance needs with USDM"