- published: 07 Mar 2016
- views: 43918
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]
Kavya Madhavan (Malayalam: കാവ്യ മാധവന്) is an Indian film actress who works in Malayalam cinema. She made her debut in Pookkalam Varavayi (1991) as a child artist. As a heroine Kavya's debut film was Lal Jose's Chandranudikkunna Dikhil(1999) while she was in the ninth standard. It was a super hit and from then on there was no looking back. She won the Kerala State Film Award for Best Actress twice, for her performances in the films Perumazhakkalam (2004) and Khaddama (2010).
Kavya was born on September 19, 1984 in the village of Nileshwaram in Kasargod district, Kerala, India, to P. Madhavan and Shyamala. She attended Nileswaram GLP School and entered the film industry as a child artist. She learned dancing during her school days and participated in competitions. She was a Kalathilakam in a Sub District Schools Youth Festival.
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!