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The video tutorial discusses the importance of electronic audit trail review in compliance with USFDA 21 CFR Part 11 and EU GMP NX11 Clause 9. It emphasizes the need to create a system-generated audit trail for changes and deletions of GMP relevant data, along with documenting reasons for such actions. The audit trail should be available, convertible to a generally intelligible form, and regularly reviewed. Failure to adhere to these requirements may result in a warning from regulatory authorities.
