What is an Audit trail?

In this article, we will learn about what an audit trail is, why it is required, and the contents of an audit trail. An audit trail is a 21 CFR Part 11 compliance requirement. These 21 CFR Part 11 deals with electronic records and electronic signatures. Generally, audit trails capture every single action or transaction that runs on a database. An audit trail acts like a tracker, which can track any changes made to the recorded data.

When you attempt to modify the data, if an audit trail is present, the system will prompt you as to why you are modifying data and capture who is modifying the data, his signature, and the date and time of modification.

So, the Audit trail consists of

• Date and time stamp: When the data was changed including time
• User sign: Who has made the changes
• Modification if performed: What changes are made, previous values and new values.
• Reason for the modification of data: Why the changes are made
• This above information is collected by the system.

Importance of Audit Trail: The main purpose of the audit trail is to ensure the data integrity, authenticity and the reliability of the electronic records that are used and to enable the compliance with the regulatory requirements.