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
Cell: (410) 231-8900
Washington, D.C.