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Considerations for Formally Validating Software in Laboratories Supporting of CLIA Genomic Assays

1 hour, 4 minutes

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June 03, 2015

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During this webinar, we will discuss practices and important learnings from a system validation for a large-content oncology-based genomic assay that meets CLIA requirements. In addition to extensive wet lab analytical validation, this assay also received extensive review of validation materials that included confirmed complex variants as well as thorough system development, review, and testing of the bioinformatic software and systems that comprise the assay and transform its data.

The field of bioinformatics, once research-focused, is now being used as a game-changing clinical tool signifying a need to integrate molecular biology, statistics, computer science, and software/systems engineering. In this move from research to clinical, a number of key issues arise that need to be addressed:

  • What are the special clinical validation considerations from the viewpoints of overall design, wet lab performance, suitable reference material, and utilizing software-intensive systems?
  • Best approaches to evolve the assay as more samples are process and limits are more thoroughly tested?
  • How is patient risk affected for broad-spectrum genomic profiling assays? Expected impact on timelines from concept to formally validated system (lab and software)

Key Learning Objectives:

Webinar attendees will learn:

  • The importance of determining and implementing proper validation design
  • The importance of software processes and allotting adequate time for system validation execution and documentation, including Part 11 solutions
  • Important considerations for reference material that are a key aspect of the validation to determine accuracy, along with reproducibility
  • Prudence measures for use of 3rd party groups who format and/or consume the test information

Who Should Attend:

  • Lab Directors or Associate Directors, Key Stakeholders in CLIA labs, Bioinformatics managers and professional, IT Directors and associated professionals associated with molecular laboratories, Medical Directors, Research MDs, Primary Investigators, genomics-oriented professionals, consumers of genomic tests, patient advocacy groups