Title 21 CFR Part 11 is an integral part of Code of Federal Regulations that handles FDA guidelines on electronic signatures and records in the United States. Part 11, as it is referred to as, mentions that electronic records and signatures are reliable and trustworthy and can be equated to paper records. Part 11 of the chapter mandates medical device manufacturers, biologics developers, drug makers, CROs, biotech companies and other FDA regulated industries to execute controls and audits.
These controls include audit trails, system and software documentation, system validation and electronic signatures in the process of electronic data maintained to show compliance to FDA rules.
These guidelines hold good for electronic submissions to the FDA and does not include paper submissions through electronic medium. Although the Final Rule was declared in 1997, several annexes in the form of industry guidelines were released subsequently to handle specific areas that needed to be addressed.