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Pharmaceuticals / Inspections and Audits

Former FDA Official Shares Tips for Data Integrity Compliance

March 9, 2018

As part of its heightened focus on data integrity the FDA has increased the sophistication of its inspections to identify hard-to-find data violations, according to a former CDER official who shared data integrity compliance tips in an FDAnews webinar Wednesday.

Mark Schwartz, former deputy director of CDER’s Office of Compliance and Biologics Quality  and now an advisor in private practice, noted the FDA’s shift in focus towards data integrity stemmed from the 2008 heparin scandal, when contaminated raw heparin stock imported from China led to more than 80 American deaths.

The FDA has focused on numerous data integrity issues in the past year and a half, such as noncompliant electronic record systems, reviews of QA and QC data showing duplicate testing and testing off the books, and firms having uncontrolled documents like paper test reports and lab notebooks, he said.

Documentation of testing analysis and other activities must be done at the time of performance, Schwartz noted. Waiting to document results even 15 to 20 minutes after testing would be problematic for the agency, he said.

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