Date of Award
Master of Science (MS)
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 system requires that the company provides documented proof that regulatory standards are met and electronic procedures have been tested and can assure quality results. A review of current literature examines how the industry utilized electronic validation after the introduction of 21 CFR Part 11. Finally, a case study is presented to see how a current company maintains its electronic validation system. The objective of this study is to look into a current company’s knowledge of regulatory compliance as well as its strengths and weaknesses of its validation system.
DeCouto, Victor and Singh, S, "Electronic Validation in the Pharmaceutical Industry" (2016). Mathematics and Computer Science Capstones. Paper 28.