PDF file (392 KB)
St. Gobain Ceramiques Avancees Desmarquest, 2002-04-26
"You need to property validate the xxx furnace process. Please supply a complete proposed validation protocol for the xxx furnace. This protocol should specifically address if any aspect of this furnace is computer controlled and how the software will be validated."

PDF file (192 KB)
Sysmex Corporation, 2002-01-22
"There were no procedures for review of source codes in design controls for software validation, and there is no assurance that all lines and possibilities in the source codes are executed at least once."

PDF file (518 KB)
Medical Device Services, Inc., 2001-12-13
"Failure to validate computer software for its intended use according to an established protocol prior to approval and issuance, and document the results of these validation activities, as required by 21 CFR 820.70(i). For example: a. The associated computer hardware and software used to identify incoming devices. b. Software used to control the production and assignment of work orders and the control of master SOPS. c. The software and hardware used to print labeling."

PDF file (273 KB)
Sorenson Development, Inc., 2001-10-17
"Revalidation of the microprocessor software used in the Palm Pump has not been completely performed following an engineering change in April 2001. Additionally, computer and/or automated data processing system software used in production and quality systems, including the use of electronic signatures, has not been validated."

PDF file (441 KB)
Luneau S. A.,