Training record- keeping - Quality Assurance - page 263

■ Authorized training records have been created by an
authorized person, for example a qualifi ed trainer.
■ Comprehensive means that a training record has been
created for every training event. For an instance of not
meeting this functional requirement, see FDA Warning
Letter to Rhytec, Inc., dated 24 April 2007: “Documentation
of training is not consistently maintained.” 9
■ Identifi able means only one training record has been
created for a given training event, and it is linked to that
particular training event.
■ Complete training records include all information about
the training event, for instance, which employee was
trained, on which SOP, by whom (the trainer), and at what
time and date. As an instance of the failure to meet this
functional requirement, consider FDA Warning Letter to
Omnicare, Inc., dated 11 January 2007: “all of the
employee records lacked the 'Supervisor Signature' to
show that the training was given.” 10

Maintained records must be inviolate, auditable, and
appropriately retained according to the following defi nitions:

■ Inviolate is defi ned as any alteration or modifi cation of the
record is traceable, and further, that repudiation of the
record is not possible. As an illustration of not meeting
this functional requirement, consider FDA Warning Letter
to Concord Laboratories, dated 11 July 2006: “Appropriate
controls are not exercised over computers or related
systems to assure that changes in analytical methods or
other control records are instituted only by authorized
personnel.” 11
■ Auditable means that every use of the record leaves an
audit trail. As an example of the failure to meet this
requirement, see FDA Warning Letter to Concord

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