DeRoyal Cientifca Stethoscopes

DeRoyal Cientifca Esophageal Stethoscopes 5/1/98

“1. Failure to validate computer software for its intended use according to an established protocol 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). This would also be a violation of the GMP Regulation, 21 CFR 820.61. For example, the computerized xxxx software system used for materials and manufacturing management has not been validated.

The March 3, 1998, response stated that DeRoyal is evaluating the xxxx software system, and all applicable modules of the xxxx software system will be validated. A specific timeframe for completion of this validation will be included in DeRoyal’s xxxx report. Please provide validation documentation for this xxxx sotware system.

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