GAMP Part 11 Draft Guidance Issued for Review

The Good Automated Manufacturing Practice (GAMP) organization issued a final draft for review of a guidance for achieving Part 11 compliance for Electronic Records;Electronic Signatures. It is available at the link provided or go to for more information..

GAMP Part11 draft

Note: this is not an FDA Guidance. It was written by an industry organization that generally focuses on pharmaceutical manufacturing.

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