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
- 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?