Abstract
Just what is “21 CFR Part 11”?Do I need to consider it when designing lab automation software? Sure, I store data electronically, but my “official” copy is a signed hardcopy stored in my documentation control system, so Part 11 doesn't apply to me, right?These and similar questions are being asked with increasing frequency during the development process for both off-the-shelf and custom lab automation software. This article presents a brief overview of the FDA regulation concerning the use of electronic records and electronic signatures and a guide for software analysts and developers.
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