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What is an “audit trail”?
27 Jan 2019

What is an “audit trail”?

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Audit trail means a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record. .

Audit trails include those that track creation, modification, or deletion of data (such as processing parameters and results) and those that track actions at the record or system level (such as attempts to access the system or rename or delete a file).
CGMP-compliant record-keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see §§ 211.68, 211.100, 211.160(a), 211.188, and 211.194). Electronic record-keeping systems, which include audit trails, can support these CGMP requirements. 

Importance of the audit trail in pharmaceutical industry

  • The audit trail is an integral requirement of an electronic record, ensuring the validity and integrity of the record and the link between any electronic signature and the record associated with it. 
  • As today, managing, retaining and auditing of the data is having the paramount importance, and audit trail is one of the technique which ensures lack of data integrity issued in pharmaceutical industry.  
  • They can also add supportive evidence to a contract vendor audit.

What audit trial data can signify?

  • Audit trail reports can be reviewed to identify system security issues.
  • It can identify the errors in sequencing of activities
  • investigation of errors and unexpected events
  • training issues
  • data integrity events. 

Benefits of audit trail

Audit trail report reviews can significantly benefit the regulated environment manufacturer, providing detailed accounts of the activities performed on a computer and the status of the electronic records. 

Example of audit trail

The audit trail for a high performance liquid chromatography (HPLC) run should include the user name, date/time of the run, the integration parameters used, and details of a reprocessing, if any. Documentation should include change justification for the reprocessing


KPE-C-103 Executive Program in Global Drug Regulatory Affairs [EPGDRA]

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