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Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) current good manufacturing practices (cGMP) regulations. Pharmaceutical manufacturers must ensure data is reliable and [...]

The U.S. Food and Drug Administration (FDA) has issued dozens of warning letters to date in 2022, also announcing resumed inspections after pausing them amid the Omicron surge. Furthermore, a [...]

This article is part two of a two-part series focused on GMP quality audit management. The very concept of an audit puts auditors on one side and auditees on the opposite side. This is especially [...]