ADPTLLC - Data Integrity, Part 11, Fda

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FDA's Current Thinking

Inspection Guide FDA UCM125404 (pdf) Click to Download Data Integrity Presentation FDA UCM561491 (pdf) Click to Download Data Integrity and Compliance With CGMP (pdf) Click to Download D2S07-Riley FDA Drug Manufacturing Inspections (pdf) Click to Download

Data Integrity Issues

HPLC and Excel Warning Letter - August 10, 2018

Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data.

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