Training record- keeping - Quality Assurance - page 277

in a fully electronic approach to training record-keeping.
Validated electronic training tracking systems should be
employed to manage training records and training
assessments in an effective manner.
Training records can provide data to justify budget requests.
They can provide data to test the accuracy of statements
about training. The training unit's use of these records
will not have enterprise-wide signifi cance; yet, such use
can contribute to the overall impact of organizational
metrics.

11.7 Notes

1. See Margaret Hedstrom (1993) and David Bearman
(1994).
2. See Wendy Duff (1995), esp. p. 29.
3. See Duff, op. cit., p. 29
4. See Duff, op. cit., pp. 33-5. These are functional
requirements of record-keeping, not necessarily GXP
regulatory requirements. As we shall see, the functional
requirements do have GXP implications. For the current
situation on organizational compliance, see Roger
Matus (2007) and Darwin Stephenson (2007).
5. See Chapter 5.
6. Available at www.fda.gov/foi/warning_letters/s6537c.
htm . See also “Arrow warned about quality systems,”
Reading Eagle , 16 October 2007.
7. Federal Register , Vol. 62, No. 54 (20 March 1997),
“Rules and Regulations,” p. 13445. See also Gwendolyn
M. Wise-Blackman (2006): “validation must be
achievable with staff at the work site.”
8. Available at www.fda.gov/foi/warning_letters/archive/
g4601d.htm See also “Federal Regulators Find Fault

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