US FDA

FDA Data Integrity and cGMP Compliance

ALCOA+ in depth, the most common data integrity failure patterns FDA cites, and how audit trail review fits into routine oversight.

What this course covers

This course goes beyond a surface definition of ALCOA+ into the specific failure patterns FDA cites most often in data integrity warning letters: backdated records, shared login credentials, deleted or overwritten data, and audit trails that exist but are never reviewed. It also covers how routine audit trail review should actually function day to day, not just as an inspection artifact.

Who this course is for

QA and QC laboratory staff generating or reviewing GMP records
IT staff supporting systems that hold GMP data
Site leadership building or auditing a data integrity program

What you'll learn

FDA's data integrity expectations and the ALCOA+ framework in practical depth
The most common data integrity failure patterns cited in recent FDA warning letters
How routine audit trail review should function as part of daily QC operations
The relationship between data integrity and Part 11 electronic record requirements
How to build a genuine data integrity culture rather than a checklist compliance exercise

Why it matters

Data integrity has been one of FDA's top enforcement priorities for years, and it is rarely a single bad actor. Most data integrity findings trace back to a system or a workload pressure that made shortcuts easier than doing it right. This course addresses both the technical requirement and the operational conditions that create the failure.

Included in the full GMPify subscription

Completion certificate, PDF slide download, and access to the complete GMP course library from day one.

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