Any attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals. The procedure and conditions under which such override takes place must be documented. When properly implemented, electronic record keeping provides an equal or greater benefit to the business enterprise than using traditional paper records. Therefore, whenever possible, food manufacturers should acquire closed systems to minimize the outlay of such resources. Furthermore, FDA provides presentations and meetings in trade and professional groups and to individual firms.
Documents covering frequently asked questions and a video are also available.
A Survey on the Use of Computer-Integrated Manufacturing in Food Processing Companies. The Federal Register. Department of Health and Human Services. Food and Drug Administration 21 CFR 11 Docket Number. March 20, 1997.