Biomedical Engineering Reference
In-Depth Information
At the second level of requirements, the training record-
keeping system (Level II) - whether electronic, paper based, or
hybrid - must be
implemented
,
responsible
,
consistent
, and
appropriately backed up
according to the following defi nitions:
■
Implemented
means that training events can be duly
recorded in the system.
■
A
responsible
system's controlled documents (i.e., SOPs for
training record-keeping) are written and followed, plus the
procedure clearly identifi es the responsible party for each
task.
5
As an example of the failure to meet this functional
requirement, and its GXP implications, consider FDA
Warning Letter to Arrow International, dated 10 October
2007: “According to procedure #CHR-001. 'Training
Administration, Documentation, and Record-keeping
Procedure,' your fi rm has 30 days to complete the training.
One training requirement was over six months late.”
6
■
Consistent
systems have been validated, so identical
processes generate identical outcomes. Vendors sometimes
suggest that their software has been validated or audited.
However, FDA has specifi cally stated that the organization
using the software must validate it for that situation.
7
■
Appropriately backed-up
systems protect documents from
loss or corruption by being subject to a regularly scheduled
backup. As an example of the failure to meet this functional
requirement, see FDA Warning Letter to the Cordis
Corporation in Warren, NJ, dated 1 April 2004: “. . .
validation did not include testing and verifi cation of
back-up and restoration of the electronic data fi les.”
8
The documentation of the training itself can be viewed as a
captured record
, a
maintained record
, and a
usable record
.
The required characteristics of a
captured training record
are authorized, comprehensive, identifi able, and complete
according to the following defi nitions:
