What Are Operational System

Checks According to 21 CFR

Part 11?
Operational system checks refer to measures implemented within
electronic systems to enforce the proper sequencing of steps and events
according to 21 CFR 11.10(f).
These checks help ensure that operations are performed in the intended
order and that any deviations or unauthorized actions are detected and
addressed promptly.

What Training Requirements

Are Required for 21 CFR Part
11 Compliance?
Training requirements required for 21 CFR Part 11 compliance specify that
individuals who use electronic record and signature systems have the
appropriate education, training, and experience to perform their assigned
tasks according to 21 CFR 11.10(i).
Training records are documented proof of the training conducted in a
company. These records are subject to the same requirements as any
electronic record within the scope of 21 CFR Part 11 and are subject to the
same controls.
You can learn more about the requirements for training records according
to 21 CFR Part 11 by reading our article.

What Are Device Checks

According to 21 CFR Part 11?
Device checks are procedures implemented to verify the validity and
reliability of data input sources or operational instruction in electronic
systems, as defined by 21 CFR 11.10(h).
These checks assess the integrity of the devices, such as terminals, used
to interact with the system. By conducting device checks, companies can
ensure that the data entered, or instructions provided through the devices
are accurate and appropriate for the intended operations.