One major benefit that computer systems have on the pharmaceutical industry is that they enable us to keep reliable and up-to-date electronic records which are easier to process, store, and retrieve. Due to the advancement of information technology, management of health records has become very easy. ...

21 CFR Part 11 is a regulatory framework designed by the FDA to guide drugmakers on how to create, manage, and maintain electronic records and electronic signatures. It also says under what conditions drug makers become eligible for compliance with this regulation. The term comes from Title 21 of the ...