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19:06
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ProfTalks
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 ...
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