In recent years, several FDA warning letters have been issued for deficiencies in data integrity in the pharmaceutical industry. In 2016, it was reported that over one-third of all regulatory actions worldwide were related to data integrity issues. In order to avoid data integrity compliance issues, it is necessary to have a thorough understanding of recent standards and regulations, such as 21 CFR Part 11, MHRA: GxP, EU GMP Annex 1, the FDA Data Integrity and Compliance with cGMP, and the WHO Good Data and Record Management Practices. This paper walks you through some of the key provisions laid out in these documents.

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Guide to GMP and FDA Data Integrity Requirements

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