Biomedical Engineering Reference
In-Depth Information
managers of the need for retraining on these
documents. Automating these processes makes it
much easier to keep employee records updated, and is
an important element in FDA compliance.
24. See Tammala Woodrum, op. cit., esp. pp. 162-3 on the
problem of organizational “policies that potentially
expand the scope of Part 11.” FDA has indicated that
Part 11 was never intended to “signifi cantly increase the
costs of compliance to an extent that was not
contemplated at the time the rule was drafted,” nor was
it intended to “discourage innovation and technological
advances without providing a signifi cant public health
benefi t.” See Offi ce of Compliance, CDER, op. cit. A
hybrid record-keeping system might best address the
situation where the vast majority of training documents
would be maintained in electronic form, and the few
exceptions would be managed in paper form.
25. See Jack Phillips and P. Phillips (2007) and Jack Phillips
(2007), esp. p. 18.
26. Chris Moore (2007) refers to the number of seats
occupied in training sessions as “fi ll rates.”
27. It is not the case, contrary to Wise-Blackman, op. cit.,
p. S-10, that “documenting the transfer of knowledge
about the SOP is best accomplished through a web-
based system that incorporates short quizzes as a
prerequisite to receiving approval for training,” because
there is a substantial legal exposure to the use of
unvalidated KTAs (short quizzes), and there are serious
costs to validating KTAs. The trainee's completion of
prerequisites would best be ascertained through a SDA,
as would the documentation of trainee profi ciency.
28. The quotation and fi gure are from Harold D. Stolovitch
(2007).
