Data Integrity

– 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

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?

Sharlin Consulting, LLC.

Joshua Sharlin, PH.D

 

[email protected]

Cell: (410) 231-8900

Washington, D.C.

Get In Touch

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