North American Science Contract Test Laboratory 11/24/98

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 xxxx 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).

Failure to maintain complete data from all tests necessary to assure compliance with established specifications and standards [21 CFR 211.94]. For example:
(a) The Customer Service Unit’s (CSU) xxxx database program which generates the sample test worksheets that are identified by sequential sample numbers, allows for the multiple printing of these worksheets. Copies will have the same sample number as the original without any indication which version is the original and which is a subsequent copy. Further, there is no audit trail within the computer that identifies how many worksheets have been generated for a given sample number (FDA 483 observation I.1f).

SoftwareCPR keywords: Software validation, security, drugs, pharmaceuticals