Electronic signatures: A computer-based model oriented to 21 CFR Part 11.

摘要

This project presents the development of a computer based model for electronic signatures that meets the requirements of the Code of Federal Regulations in the norm titled FDA 21 CFR Part 11. The proposed model allows the creation, administration and control of users into a system, as well as, monitor their activities. The model identifies a user through a username and password, and incorporates diverse mechanisms to protect the identity of an individual. It allows executing a complete and detailed audit trail of all the activities carried out in the system related to the login process. A relational database is designed to manage the information. The software is developed using Microsoft Visual Basic. An evaluation of the model is performed under a Human Machine Interface environment in order to illustrate the viability and applicability of the proposed model.