What type of eporting capability on audit trail data should be supported?
According to Part 11 11.10 (e) audit trails must be secure, computer-generated and time-stamped to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying. Audit trails should say ‘who did what to your records and when (why for GLP)’. Part 11 does not specify the format for audit trials. This should be discussed in a forthcoming FDA guidance document for Part 11 audit trails.
