Extensive Part 11 Erecs;esig Warning Letter

The document at the link listed is an excerpt from a warning letter issued to Linweld Inc. on 8/2/99. This excerpt cites Part 11 violations extensively. Its an example of detailed Part 11 enforcement.

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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