Q: If an audit trail module for a training software package doesn’t track adding or deleting an attachment (such as an attendance sheet) to a course, a company should not use electronic records for training evidence…correct?
I’m assuming in this scenario a company should continue to keep hard-copy records of training evidence, because the audit trail would not record when or if an administrator adds or deletes an attachment — which in this case would be the signed evidence of training.
A: You are correct. Part 11 is very clear that the audit trail must record the date and time of all operator entries, including the time electronic records are created by the operator.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]The administrator’s actions of adding or deleting a training attendance sheet to the training record would need to be captured in the audit trail.[/pullquote]
In this case, the operator is the administrator, so the administrator’s actions of adding or deleting a training attendance sheet to the training record would need to be captured in the audit trail.
If such additions or deletions can’t be captured in the audit trail, then it’s best to keep the training sheets in hard-copy form. Make handwritten notes on them, stating when they were added to or removed from the electronic records. This would be a mitigation for the lack of a complete audit trail capability.
Answered by Janis Olson, EduQuest VP of Regulatory and Quality Services, 22 years as an FDA investigator and regional FDA director of information management resources, and co-instructor of EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 Training Class.