GE Medical 6/16/96 X-Ray France
Failure to validate software programs by adequate and documented testing, when computers are used as part of an automated production or quality assurance system, as required by 21 CFR 820.61. For example, the software control processes have not been validated to correct the most serious faults.
Failure to subject any change in the manufacturing process of a device to a formal approval process, as required by 21 CFR 820.100(b)(3). For example, the change control for the Senographe and Saturne safety FMI/upgrades were inadequate because the software validation procedures do not require that all known problems be addressed, but only that the most serious problems be addressed.