Failure to exercise appropriate controls over computer or related systems to ensure that changes in records are instituted only by authorized personnel; failure to concurrently maintain a record from which unsuitable donors may be identified; and failure to maintain and/or follow standard written operating procedures to include all steps to be followed in the collection, processing, storage and distribution of blood and blood products.
1. Failure to exercise appropriate controls over computer or related systems to assure that changes in records are instituted only by authorized personnel [21 CFR 211.68(b)] in that:
a. An employee user name and computer password were publicly posted for other employees to use to access the _____ Data Management System. During the inspection another employee who did not have an established user name or password was observed obtaining access to the _____ Data Management System utilizing the posted user name and password.
b. The _____ Data Management System training procedure requires competency in performing computer operations to be evaluated annually. An employee who performs donor registration procedures, makes changes to critical demographic fields in the _____ Data Management System, and who was observed to have posted a user name and password for public use, had not been re-evaluated since January 26, 1996.
