Lab Systems

USDM Life Sciences 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:

  • Vendor and Software selection
  • Laboratory Information Management Systems (LIMS)
  • Scientific Data Management System (SDMS)
  • Electronic Lab Notebooks (ELN)
  • Software validation (21CFR11, ISPE GAMP, GLP)
  • Fully electronic/paperless predicate-rule compliant systems
  • Instrument/system integration
  • Customized multivendor lab Instrument qualification
  • Network infrastructure design, installation and qualification
  • Complimentary practice areas – GRC, ECM/Content Management, ERP, Business Intelligence

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:

  • Cost-effective compliance solutions
  • A uniform set of instrument qualification protocols typically found across different labs, departments and sites
  • Protocols matched to your configuration and intended business use
  • Reduced time between procurement and commissioning into production
  • More meaningful and defendable validation documentation with a higher level of regulatory acceptance by FDA, Health Canada, MHRA and other regulatory bodies
  • Enhanced confidence in instrument/system performance post "go-live"

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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