Biomedical Engineering Reference
In-Depth Information
work assignments accordingly. Thus, the training records are
used proactively to control and direct the organization.
Auditors include internal and external auditors (e.g.,
regulatory investigators, etc.) who are interested in whether
the signer of the particular operational document (e.g., a
batch record) was trained to the appropriate SOP before
signing. The auditor reviews the signer's training history in
light of a set of documents being inspected. In these cases,
the training records provide evidence of the organization's
past fulfi llment of its regulatory obligations.
11.2 Record-keeping requirements
As the Electronic Records Project at the University of
Pittsburgh has indicated, record-keeping requirements can
be considered at several levels - that of the
organization
, that
of the record-keeping
system
, and that of the
record
itself
(Figure 11.1).
To begin with the highest level of requirements, the
organization (i.e., Level I) must be
compliant
with all relevant
legislation, regulations, and best practices concerning
training records.
4
Figure 11.1
Levels of record-keeping requirements
