What are the requirements of Audit Trail in CRF 21 Part 11?

What are the requirements of Audit Trail in CRF 21 Part 11

In the 21 CRF Part 11, the FDA established guidelines for electronic records and electronic signatures. A fundamental aspect of compliance in clinical trials is maintaining a secure and comprehensive audit trail for all actions performed within the system in which a study is being conducted.


Here we share the key requirements you must have in mind about audit trails based on the 21 CFR Part 11:

Time Stamping
  • The user actions and system events must be recorded with a precise timestamp, including date and time.
  • The timestamp should be based on a reliable and synchronized clock, typically a central server time.
User Identification
  • Every action in Trial360 is linked to a unique identifier for the user who performed it.
  • This could be a username or another secure identification method.
Action Detail

The audit trail must capture sufficient detail about each action, including the specific type of action, the data element affected, and the previous and new values of any changed data.

Inmutability and Security
  • The audit trail data must be unalterable and protected from unauthorized access or modification.
  • For Integra IT, this involve implementing digital signatures, encryption, and audit trail backups.
Review and Archiving

The audit trail data must be archived securely for a defined period, aligned with regulatory requirements and study retention policies.

By adopting Trial 360 you can incorporate these requirements into your clinical trials, ensuring data integrity, regulatory compliance, and, ultimately, the success of your research efforts. Contact us if you’re interested in knowing more about how we ensure compliance and quality in our software solutions.

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