Company: Surgilight IncProduct: Optivision Laser System Date: 4/20/04 Validation of Borland Compiler is incomplete because software used to control passwords was not addressed (FDA 483, Item #3) Complaint #17 dated December 17, 2001, references software locked up due to possible computer time and/or patient file recreation. Failure not determined Your firm’s design validation failed to...Read More
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