Transaction Safeguards - 11​.300 (d)

21 CFR Part 11:

“(d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management.”

Procedures should define how to handle any unauthorized attempts to use a person’s ID and/or password. This will depend on the technological controls to identify the unauthorized attempted use.