May

1998

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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DeRoyal Cientifca Stethoscopes

Amy Sellers

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