In March of 1997, FDA issued final part 11 regulations (21 CFR Part 11) that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, were intended to permit the widest possible use of electronic technology, compatible with FDA’s responsibility to protect the public health.

This paper answers some of the most commonly asked questions regarding °B Connected, a monitoring solution developed by B Medical Systems, that generates electronic records and 21 CFR Part 11.