WARN 12/05/96 Lady of the Lake Blood Bank

Deviations noted included: 1) lack of proper validation of computer system software; 2) failure to establish and implement adequate computer security in allowing software vendor unrestricted modem access and not consistently documenting this access; 3) not conducting a secondary review of computer software modifications; 4) lack of a computer hardware and software change control SOP; and 5) lack of verification that software modifications validated on the “test” system are identical to the modifications implemented later in the “live” system.