Day

June 16, 1996
16
Jun

GE Medical X-Ray FranceProduction Software

June 16, 1996
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...
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