Device Testing - 11.300 (e)
- Last UpdatedFeb 12, 2025
- 1 minute read
21 CFR Part 11:
“(e) Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner.”
Procedures need to define the testing to perform and when it should be performed, including the frequency of the periodic tests.