Aventis Bio-Services

Company: Aventis Bio-Services
Date: 6/29/01
Product: Blood Products

There are no written procedures and controls in place to assure that the manual permanently deferred donor files are checked when determining the suitability of new donors. Not all permanently deferred donors are included in your _____ computer system. In order to verify that a new donor is not permanently deferred, screening personnel must access the manual file. However, there are no written procedures instructing employees to check the manual file.

Employee training on the use of the new _____ computer system, which is used in donor screening and product processing, was not complete. Employees were not very familiar with this computer system. Additionally, the center director had not received any training on this computer system even though he retains a high security level for data entered on this computer system.

The validation and installation records for the _____ computer system were incomplete. Installation of this system was performed on 11/17/2000, however the validation study was not formally approved until 4/19/2001. The validation study was signed off even though incomplete testing was noted in the following areas: _____

FDA District: Atlanta

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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