Physical Sciences and Mathematics Commons^™

Electronic Validation In The Pharmaceutical Industry, Victor Decouto, S Singh

Mathematics and Computer Science Capstones

The authors investigate whether or not companies within the pharmaceutical industry still have a hard time effectively designing and following an electronic validation system. With increased data integrity issues from electronic systems, the FDA introduced 21 CFR Part 11 in 1997 to allow for the use of electronic signature and records for processes within the pharmaceutical industry. This regulation also required that the computer and electronic systems be available for audits and inspections by the FDA. In order to comply with 21 CFR Part 11 and adapt to new technology, companies must have an electronic validation system. The electronic validation …