FDA publishes Q&A on Data Integrity

Did someone declare December Data Integrity month when I wasn’t looking? Though recent FDA announcements really mean that every month is data integrity month.

In the spirit of giving  the US published on 13Dec2017  “Data Integrity and Compliance with Drug CGMP: Questions and Answers.” This guidance updates a draft version released in 2016 and has been revised to include additional information on the agency’s current thinking on best practices and covers the design, operation and monitoring of systems and controls to maintain data integrity.

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