Warning Letters 2016 – Data Governance & Data Integrity

by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief In 2015 we published a collection of FDA GMP warning letters that included deficiencies in data governance and data integrity.  Here we provide the same information for 2016 drug GMP warning letters. These should serve as a resource for GMP audit staff and QA staff …

Warning Letters 2016 – Data Governance & Data Integrity Read More »