ABSTRACT
Audit trails are the most important technical consideration and the most important element of Part 11. These are generated when data, which is stored on durable media, is modified. Audit trails ensure that changes to the electronic records do not obscure the source data. Electronic data as well as data collected manually can be amended and the amendment must be recorded and justified2. Changes to electronic records will always require an audit trial3; these changes must not obscure the original record. Audit trails must include the original entry, the new entry, the reason for the change, the date and the time of the change, and the electronic signature.
