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Data Integrity and the Preapproval Inspection

An Inspector’s Experience

Data integrity has always been an important part of application review and cGMP inspections. In recent years, however, it has become more important due to the U.S. FDA’s renewed emphasis on the integrity of data in electronic and paper-based formats. FDA has seen more data integrity issues of late, possibly due to the increased use of computers, automation and complexity of processes. The recent FDA draft guidance, which came out in April (1), is an important step by FDA to clarify the current thinking and policy about data integrity.