FDA releases new 21 CFR Part 11 guidance document

In a May ’03 article titled ''FDA’s New Initiative,'' I mentioned how the U.S. Food and Drug Administration (FDA) was undertaking a new initiative to enhance its entire current-Good Manufacturing Practices (cGAMP) program, including Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures—also known as 21 CFR Part 11.

09/18/2003



In a May ’03 article titled ''FDA’s New Initiative,'' I mentioned how the U.S. Food and Drug Administration (FDA) was undertaking a new initiative to enhance its entire current-Good Manufacturing Practices (cGAMP) program, including Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures—also known as 21 CFR Part 11.


Earlier this month, the FDA made available a new guidance document describing its current thinking regarding the scope and application of 21 CFR Part 11.

FDA’s guidance continues to underline the importance of predicate rule requirements and the role of risk assessment. It references existing FDA guidance documents on software and computerized systems, and the ISPE Good Automated Manufacturing Practice (GAMP 4) Guide for Validation of Automated Systems—also described in the May ’03 article.

Click here to read the FDA guidance document

Click here to read ISPE’s Part 11 briefing statement and obtain additional information about GAMP 4.

—Dave Harrold, senior editor, Control Engineering, dharrold@reedbusiness.com





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