STARLIMS

Laboratory Information Management Systems (LIMS) provide the platform for managing a wide range of processes used in laboratories including the management of:

  • Samples
  • Instruments
  • Standards
  • Laboratory Users
  • Plate Management
  • Information Gathering
  • Calculations

USDM has developed a comprehensive solution to support Life Sciences companies with comprehensive testing of regulatory requirements for STAR LIMS. Our Validation Accelerator Package (VAP) provides validation assistance with core regulatory requirements for the following LIMS functionality:

  • Sample Login
  • Barcode Labels Printed
  • Sample Receipts Issued
  • Work Assignment
  • Samples Organized
  • Work Lists Created
  • Instrument Parameters Sent
  • Results Entry
  • Manual or Automatic Calculations
  • Integrated Data Capture
  • Review & Approval
  • Re-Sample/Investigate
  • Released with Electronic Signature
  • Reports & Queries
  • Integrated SQC
  • Trend Analysis
  • Integrated Crystal Reports

USDM's STARLIMS LIMS 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 identifies upcoming patches and updates and provides a full maintenance program for our Watson clients. Recommendations for required testing are made to ensure our clients an effective, efficient validation maintenance process.

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

USDM has been successful across many STARLIMS LIMS 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.

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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