Access DB validations EP MedSystems – Excel

Company: EP MedSystems
Date: 7/10/01
Product: Cardiac Catheters

Your firm failed to validate several computer databases that are used for quality functions including your Access database, your _____ software, and your MS Excel spreadsheet program as required by 21 CFR 820.70(i).

FDA District: New Jersey

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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Access DB validations EP MedSystems – Excel

Amy Sellers

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