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.

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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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