Bayer Corp.

8. Failure to adequately validate the _____ system software used for inventory tracking of quarantined, rejected, and released materials for finished products and for release and materials transfer functions [21 CFR 211.68].

About the author

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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