Jan

2001

Aventis – LIMS Security

Company: Aventis Behring L.L.C.
Date: 1/22/01
Product: Biological products
Product category: Human Drugs
Failure to exercise appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)] in that changes were not implemented to restrict access and entry of data by Chiron Behring employees after they were no longer entering sterility testing results into Aventis Behring’s laboratory information management system (LIMS).

FDA District: Rockville, Maryland

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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Aventis – LIMS Security

Amy Sellers

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