FDA 21 CFR Part 11: Difference between revisions
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New page: == Description == FDA regulations outline criteria for accepting electronic records, for documenting and validating authorized change processes to systems, and require backup power and ba... |
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Latest revision as of 00:15, 10 December 2008
Description
FDA regulations outline criteria for accepting electronic records, for documenting and validating authorized change processes to systems, and require backup power and backup software for key systems. This regulatory requirement is mandatory.
Scope
Applies to the life sciences and pharmaceutical industry.