Every Program, Record and Entity in the application has detailed audit logging enabled which records all actions carried out including;

  • When the record is created.
  • When it is moved to another stage.
  • When it is printed.
  • When it is emailed.
  • When it is changed, by whom and the reason for change.
  • When any attachments are added or removed.
  • When it is completed.

1. Accessing the Audit Log

1.1. Select Record to access Audit Log

Select Record to access Audit Log

Click ‘Actions > Audit Log’.

1.2. Audit Log will open

Audit Log will open

2. Adding a Note

Adding a Note
  1. Type the body of your note.
  2. Click submit.

3. Printing the Audit Log

3.1. Press Print

Press Print

Click the print icon.

3.2. And Print again

And Print again

Click print again to open the print-friendly page.

4. FDA 21 CFR Part 11 Audit Logging

FDA 21 CFR Part 11 Audit Logging

If you have FDA 21 CFR Part 11 turned on then every time you change a record you will find a PDF copy of the record, prior to change, in the audit log. Simply click on the view link beside the change to see the record right before the change was made.