Ultramedic Ltd. 11/25/98 Infusion Pump Analyzers
6. Failure to have an established protocol to validate computer software for its intended use when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, there is no validation protocol for the validation study performed on the software of the IDA-4.
In addition, you need to reevaluate and modify the entire “B4 Design Control” procedure to include all elements of 21 CFR 820.30, Design Controls.
