Laboratory Systems
Over the past 4 decades, compliance and validation have continued to evolve and can be viewed as a continuum – from retrospective to prospective validation to the current risk-based approach.
While the big cost cutters of the past few decades continue to apply, as we approach the next decade of 2010, life sciences companies are looking to:
- Decrease validation costs
- Accelerate instrument and software deployment times
- Achieve and maintain a validated state of compliance
- Improve ROI
- Simplify, unify and optimize compliance objectives
USDM offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists capable of delivering:
- Instrument qualification
- Instrument/system integration
- LIMS and SDMS validation
- Electronic Lab Notebooks
- Fully electronic/paperless predicate-rule compliant systems
As the market leader in providing best practice regulatory compliance solutions to the life sciences industry with seasoned consultants with extensive laboratory domain, regulatory compliance and risk management expertise, USDM can assist you with attaining:
- A scalable compliance approach focused on a scientific risk-based rationale focused on where your greatest risk exists and minimizing non-value added testing or documentation
- Cost-effective compliance solutions
- A uniform set of automated protocols which will harmonize the "patchwork quilt or mosaic" of instrument qualification protocols typically found in different labs, departments and sites
- Protocols matched to your configuration and intended business use giving you the comfort, assurance and independence that a 3rd party regulatory compliance expert brings to the validation of your laboratory instruments and systems
- Reduced time between procurement and commissioning into production
- More meaningful and defendable validation documentation with a higher level of regulatory acceptance by FDA, MHRA and other regulatory bodies
- Enhanced confidence level in instrument/system performance post "go-live"
Let USDM's harmonized enterprise compliance solutions help you to maintain compliance with regulatory and quality guidelines without sacrificing lab throughput and productivity by delivering the simplicity and consistency needed.
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"
