| DESCRIPTION |
Provides mechanism for documenting the mandated validation of the Blood
outcome of the review, the date/signature of approval and the date
of implementation.
This file offers longitudinal tracking of validation of the software
to include the release of new versions, the installation of patches and
the installation of any local modifications.
The content and the formatting of the file is consistent with the
worksheets provided in the Blood Bank User Manual and the Technical
Manual and complies with the requirements of the the American
Bank software options. Data entry in the file is NOT intended to
Association of Blood Bank and the Food and Drug Administration.
replace the mandated documentation of the validation testing, including:
(1) observations from testing, e.g. screen prints, logging files,
printed reports, written transcriptions, data tapes, data disks, etc.,
(2) a record/log of unusual occurrences, bugs, deviations from the
BB User Manual & resoltuion, or (3) final approval by other responsible
individuals, including the BB Medical Director and the LIM. It MAY
be used to replace the documentation of the review, the acceptability/
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