04

Sep

2008

Mavidon Medical Products

0

Recipient: Mavidon Medical Products
Product:Class II Mavidon Medical Electrode Jelly.
Date: 8/8/2008

7. Failure to validate, according to an established protocol, computer software for its intended use, when that software is used as part of the Quality System or part of production as required by 21 CFR 820.70(i). The regulation under 21 CFR 820.70(i) requires that when computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented. Your firm implemented in 2007 a computer automated system for manufacturing and inventory control for raw material, however there is no validation of the software.

We have reviewed your response, dated June 24, 2008, and have concluded that it is inadequate because software validation should have been completed prior to manufacturing and release of your product. Your response to this observation is inadequate because it does not describe the specific steps that your firm will take at the present time to ensure compliance with the requirements of 21 CFR 820.70(i).

FDA Florida District Office

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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