File History (Audit Trail)

Notes: This log is intended to comply with the cGMP audit trail requirements of the 21 CFR, Part 11.

Press the vertical ellipsis icon , and click on the Audit Trail icon, once done you will see the activity log related to the selected file in chronological order.

Audit Trail History Example

By pressing the print icon , the system automatically downloads the audit trail report.

Audit Trail in PDF Example

File History (Audit Trail) for Actions and Training

Notes: This log is intended to comply with the cGMP audit trail requirements of the 21 CFR, Part 11.

Press the vertical ellipsis icon , and click on the Audit Trail icon, once done you will see the activity log related to the selected file in chronological order.

Attachment - Audit Trail History Example

For Actions, you can go directly to the record (Investigation request or Investigation) search for the area of actions, and click on the Audit Trail icon.

When you print it will include a stamp with a unique control number along with the name of the user who initiated the print with a stamp detailing the date/time it was made, all this information can be found in the document footer, as shown in the example below. Designed to comply with the cGMPs, ALCOA, ALCOA+, and other data integrity and security standards associated with forms and documents.