14
Dec
1998

Knoll Pharmaceutical

0

Knoll Pharmaceutical 12/14/98

Your firm’s equipment qualifications for the Amsco SG-116 autoclave and the computer control system for the 60″ film coating pan were inadequate.
SoftwareCPR keywords: software validation, CDER, Drugs, Pharma

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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