The Device History Record is a form in fillable PDF format. Worker opens the PDF from a secure source within the local network. The only thing they can change is checkmark Pass/Fail, Yes/No and enter serial numbers in the allowed fields. Then after the assembly process is done for each procedure, the worker prints the DHR, signs and dates it by hand, to verify the accuracy of data entered. No re-printing or saving PDF’s is allowed.
Now, if you don’t save the electronic record, just print and sign. How do you defend compliance for item (e) below, regarding audit trail? Is it applicable?
(e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. 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.
Thank you for your comments in advance.