Biomedical Engineering Reference
In-Depth Information
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34R
Training record-keeping
Abstract:
This chapter examines training record-keeping
in the life sciences and other regulated industries. Record-
keeping is necessary for any training system that is subject
to audit. This necessity may come to be recognized as early
as the point in program development when training
assessments are created. It certainly comes to be recognized
when the program is being implemented (or even piloted)
and actual training records are generated. This
documentation could include training records (or
attendance sheets), training assessments, and curricula or
individual training plans (ITPs). These documents could
be in electronic form or hard copy. This chapter will fi rst
consider some strategic aspects of record-keeping, then
turns to tactical issues.
Key words:
accessible record, appropriately retained
record, auditable record, authorized record,
backed-up system, captured record, complete
record, compliant organization, comprehensive record,
consistent system, exportable record, identifi able
record, implemented system, inviolate record, maintained
record, Part 11 compliance, predicate rule, record-keeping
audiences, responsible system, retrievable record,
usable record.
34R
