GAMP Part 11 Draft Guidance Issued for Review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 www.gamp.org 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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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