North American Science Assoc 11/24/98 Contract Testing Laboratory

Failure to maintain adequate controls over computers and related systems to assure that changes in the master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)]. For example: (1) there is no current listing of individuals who have access to the Customer Service Unit’s _____ database program or to what level of access each individual has; (2) there is no procedure in place to grant, modify or remove access privileges to this software (FDA 483 observation 1 d&e).