Laboratory Information Management Systems (LIMS)

USDM has a proven record of ensuring that our clientele's Laboratory Information Management System (LIMS) applications efficiently implement their laboratory and sample management operations in order to produce the information required for effective decision making, license applications and/or gauging drug stability and potency, among many other critical business uses.

USDM consulting professionals are experts in performing risk assessment, vendor selection & auditing, implementation, compliance and validation services using a best-practices approach that expedites the compliance process and minimizes costs along the way for our clients.  Our professionals work closely with client representatives, software engineers and end-users to ensure that requirements (e.g., business, functional and compliance requirements among others) are properly articulated for efficient testing while minimizing execution times and costs.

In addition to hands-on experience in one or more LIMS applications, our USDM consulting professionals have in-depth knowledge and expertise in the following:

  • FDA regulations (e.g., 21 CFR Parts 11, 210, 211 and 820) relevant to LIMS;
  • cGXP (i.e., GLP, GCP and GMP);
  • Development of validation documentation packages and SOPs;
  • Execution of validation/qualification protocols and test plans.

Examples of LIMS applications that our USDM consulting professionals have successfully validated include:

  • SQL*LIMS
  • LabWare LIMS
  • Beckman LIMS
  • Thermo Scientific SampleManager LIMS
  • Thermo Scientific Watson LIMS
  • STARLIMS LIMS
  • LabVantage Sapphire LIMS

Additionally, our USDM consulting professionals are well versed on business intelligence tools like SAP BusinessObjects deployed for extracting and reporting information accrued by the LIMS application.  Our consultants assist our business intelligence partners design, develop, deploy and validate their reporting solutions.

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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