Biomedical Engineering Reference
In-Depth Information
Laboratories, dated 11 July 2006: “. . . review of audit
trails is not required.” 12
Appropriately retained training records must be subject
to a retention schedule and then disposed according to
procedure. 13
Usable training record s must be exportable, retrievable, and
accessible to authorized parties according to the following
defi nitions:
Exportable records must be portable from one system to
another without loss of information.
Retrievable training records are in a form that can be
searched and retrieved within a reasonable period of time
and expenditure of resources.
Documents accessible to authorized parties must be
available to those who are authorized to access them and
unavailable to those who are not authorized. 14
After identifying two main audiences for the documentation of
training - operational staff and auditors - the training record-
keeping must possess characteristics of good documentation
management. If at each level - organization, training record-
keeping system, and documentation of training - characteristics
are present that are appropriate for that level and
proceduralized, that level will be “audit proof,” which is to
say it can survive an internal or external GXP audit, and will
moreover have business value to operational staff.
￿ ￿ ￿ ￿ ￿
11.3 Part 11 compliance
When document management is discussed with reference to
training and assessment, the topic of Part 11 compliance
frequently comes up (Part 11 refers to “Electronic Records;
Search WWH ::




Custom Search