Biomedical Engineering Reference
In-Depth Information
only a “determination that persons who develop, maintain,
or use electronic record/electronic signature systems have the
education, training, and experience to perform their assigned
tasks,” which is another example of the fi rst predicate rule
noted in Table 11.1.
22
In light of this, the documentation of training does not fall
within the scope of Part 11. What are the implications of
this limited scope? We assume throughout that this
documentation is controlled, as well as duly signed by the
party responsible for the action described. The documentation
of training can be considered as instances of what FDA has
called a hybrid situation. In such a situation, paper record
and signature components can co-exist with electronic record
and signature components, “so long as [. . .] the content and
meaning of those records are preserved.”
23
Consider the following scenario: A GXP training event -
either technical training or regulatory training - has just
occurred. All the trainees have been assessed as “successful”
in the training. There is a training record - a controlled
document - and its use is proceduralized, including entry
into a validated Learning Management System (LMS).
Trainees then sign and date the paper-training record, and
the trainer countersigns and dates the record. At this point,
the event is fully documented; the trainees are fully trained to
perform the GXP tasks. They can “touch” the product or
supervise those touching the product. Then, according to
procedure, duly authorized data entry clerks enter the data
from the training record into the LMS within 72 hours, and
sign off the entries. A duly authorized data steward verifi es
the data entries and signs off. At this point, by procedure, the
electronic record becomes the controlled document, and the
paper copy can be archived or disposed of.
Sounds straightforward; however, there have been
situations where it is assumed that all training records fall
