21 CFR Part 11 on Electronic Records: What Life Science Companies Should Know eleapsoftware.com

In the 21 CFR part, 11 many life science businesses find themselves in precisely the same position. It is a complex set of regulations and rules that have to be followed closely, and it applies to all digital systems in your company, from the tagging to your Learning Management System. And Beneath 21 CFR part 11 electronic records, the FDA defines it as, any mixture of text, images, data, audio, pictorial, or other information representation in digital form that\’s created, modified, maintained, archived, retrieved, or distributed by a computer program.
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21 CFR Part 11 on Electronic Records