Data Integrity and Compliance With Drug CGMP: Questions and Answers (FDA guidance)

FDA · Final

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Summary

FDA's question-and-answer guidance on data integrity in drug manufacturing: ALCOA, audit trail review, access controls, shared logins and when electronic data are CGMP records.

Dated events

1. ~1 Dec 2018 Final guidance published (Dec 2018) Source for Final guidance published (Dec 2018)

Official source

Official text

Source: FDA. Public domain.