USFDA Guidance for Data Integrity | USFDA Guidelines for Pharmaceutical | Easy Explanation

'Data Integrity & Compliance with Drug CMGP' Question and Answers Guidance for Industry released in Dec 2018.

Explains the details about USFDA expectation on data integrity and ALCOA principles.
Give details about controls on electronic records, metadata, audit trail, static & dynamic data, data backup, data invalidation, computer system validation, shared logins, control of blank forms/ formats, audit trail review, audit trail frequency, electronic signatures, system suitability, reprocessing of chromatograms, training on data integrity, handling of data integrity problems.

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