- published: 07 May 2016
- views: 2028
Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
Practically speaking, Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. [1]
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Don't let the silence fool you, inside I'm insane
I'm waiting, I'm calling your name
And when those voices tell me: "Don't be afraid!"
I'm not afraid
I'm falling, I'm fading away
And when I'm older, maybe I will work it out
And if you fall to pieces yeah
How are we meant to live with the life that you've given us?
Someone tell me!
Isn't all that we've done just a storm in a paper cup?
Someone tell me!
And still I search for answers buried in my brain
I'm falling the same way again
I am a fallen hero, only in my mind,
I don't mind
The memory is leaving
And now I am older, baby, I can work it out
And when you fall to pieces yeah
How are we meant to live with the life that you've given us?
Someone tell me!
Isn't all that we've done just a storm in a paper cup?
Someone tell me!