Audit Trail

An audit trail is a chronological record that provides documentary evidence of the sequence of activities, events, and changes that have occurred during the lifecycle of a process, system, or product. In regulated industries such as pharmaceuticals, medical devices, and biotechnology, audit trails are critical for ensuring data integrity and regulatory compliance.

An audit trail typically includes the following information:

  1. Date and time: The date and time of each activity or event that occurred during the process.

  2. User ID: The identification of the user who performed the activity or event.

  3. Action description: A description of the activity or event that occurred, such as a change in a record, a deletion of data, or an update to a system.

  4. Reason for the action: A reason for the activity or event, such as an error correction or an update to a process.

Audit trails are used for documenting and tracking changes to critical systems, processes, and data, and for providing an evidence trail for regulatory inspections and audits. They are also used for detecting and preventing data tampering, data loss, or data manipulation. Adherence to audit trail requirements is critical for maintaining data integrity, ensuring compliance with regulatory requirements, and ultimately ensuring patient safety and product efficacy.

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