Glenwood LLC

14. Failure to validate the software programs, Shimadzu and _____ that are used to run the laboratory HPLC equipment, during analysis of raw materials and finished products. The _____ software does not secure data from alterations, losses, or erasures. The software allows for overwriting of original data. There are no written procedures for the use of passwords, levels of access, or data back-up.

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.