VAPs for Laboratory Systems
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 SQL*LIMS. Our Validation Accelerator Package (VAP) provides validation assistance with core regulatory requirements for the following LIMS functionality:
- Lot and Batch Management
- Environmental Monitoring
- Full Sample Tracking
- Instrument Interface / Data Acquisition
- Lot & Batch Management
- Electronic Signatures
- Reports – Oracle Reports
- Stability Studies
USDM's SQL 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
Equipped with over 10 years of experience and specialization in regulated business processes, our skilled team of SQL*LIMS validation professionals can provide your organization with innovative and streamlined alternatives to industry standards.
USDM has been successful across many SQL*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.
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"
