Anyone working in manufacturing and distribution of medical devices and drugs is well versed with the ‘21 CFR Part 11’ requirements. In 1997, US Food and Drug Administration (FDA) issued regulation popularly known as “21 CFR Part 11”. The regulation aims to assure that computerized records are safe, accurate and secure. As per the regulations, the software application’s role is to ensure that the data pertaining to manufactured goods is electronically captured, manipulated, extracted and coded during the manufacturing of the product.