There are numerous differences between paper and electronic record technologies that must be addressed before an electronic system can be validated. For instance, electronic records are culled from information databases. Such databases are dynamic. In addition, all database software is slightly different, in how it is programmed and in how it operates. Worse, database elements can easily be changed at any time without evidence that a change was made and in a manner that destroys the original information.
Electronic signatures face similar issues.
It is much more difficult to falsify a paper signature and easier to detect when this has happened than it is to falsify an electronic one. In addition, paper signatures cannot be borrowed or loaned, whereas an electronic one can. These issues do not arise in paper-based systems. Therefore, additional controls are necessary for electronic signatures. The final rule provides criteria under which FDA will consider electronic records to be equivalent to paper records, and electronic signatures equivalent to traditional handwritten signatures.