These regulations implement the FDA's criteria for and authority over the use of electronic records and electronic and handwritten signatures executed in electronics recordds. FDA requires such uses to be trustworthy, reliable and generally equivaluent to paper records and handwritten signatures. Any computer system, both hardware and software controls and documentation must be readily available for FDA inspection.
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bag
fda_public
created
Sat, 23 Jun 2012 15:09:55 GMT
creator
dirkjan
modified
Sat, 23 Jun 2012 15:09:55 GMT
modifier
dirkjan
tags
CFR
creator
dirkjan