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?