FDA Final Part 11 Scope and Application Guidance

FDA CDER issued a final guidance for Part 11 as part of its redirection effort for electronic records and signatures expectation. This is available at the link provided. This guidance is generally consistent with the earlier draft guidance. It also states explicitly that FDA is planning to revise the regulation itself and it explicitly states word processors used to generate SOPs do not require validation.

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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