Sharlin Consulting, LLC

Joshua Sharlin, Ph.D.

Expert Witness: FDA Regulations
FDA Regulatory Consultant (25 Years)
Expert Witness (10 Years)

Data Integrity

My Services for Data Integrity Cases

  • I analyze data integrity issues in a lawsuit to:
    o Determine scope
    o Identify root cause
    o Determine the effects on data and conclusions derived from the data
    o Identify FDA regulations not followed

My Credentials

  • Vast hands-on experience as a software developer
  • Formerly Director of Hotel Customer Information Systems for Marriott International
  • History of solving data integrity problems
  • Former FDA reviewer

FDA’s Definition of Data Integrity

  • In a recent guidance document (here), FDA states, “…data integrity refers to the completeness,
    consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable,
    legible, contemporaneously recorded, original or a true copy, and accurate”.

FDA is Targeting Data Integrity Compliance

  • A study of Warning Letters issued in 2017 (here) determined that 68% had a data integrity component.

Key Questions from FDA Reviewers

  • Can you prove to the Agency the data you collected in the past is the same data that is
    part of your submission today?
  • Do you have evidence your data wasn’t accidentally or deliberately altered?