FDA’s Definition of Data Integrity

In a recent guidance document, 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 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?

Dr. Sharlin’s Services

 Apply an FDA reviewer’s perspective to analyzing and solving data integrity problems
 Audit for data integrity compliance
 Write SOPs for data integrity
 Create documentation of data integrity compliance
 Evaluate existing data integrity solutions and strategies
 Fix existing data integrity problems identified during submission creation or in response
to questions from FDA

Dr. Sharlin’s Credentials

  Former FDA reviewer
 Hands-on experience as a programmer and data manager. Taught programming for SAS
Institute, wrote code supporting the Consumer Price Index, and served as Director of Hotel
Customer Information Systems for Marriott International
 Over 20 years of experience providing consulting support to FDA regulated companies in the
areas of regulatory affairs, submission creation, auditing for compliance, and data analysis.
 A proven history of success in applying technical expertise and regulatory insight to solving data integrity problems

Get in Touch

Sharlin Consulting

Joshua Sharlin, PhD

jsharlin@pipeline.com

 

Cell: 410-231-8900

(Washington, D.C.)

 

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