Harper Hospital Blood Bank

Harper Hospital Blood Bank 4/13/00

Failure to perform/maintain computer validation [21 CFR 211.68] in that:
there was no validation protocol to show how the system was tested and what were the expected outcomes;

there was no documentation to identify the operator performing each significant step, date completed, whether expected outcomes were met, and management review;

there was no documentation to show if problems were experienced during the process, and how they were solved;

there was no documentation to show if the validation was reviewed prior to software implementation.

We acknowledge receipt of your letter dated March 6, 2000, which includes your response to the FDA-483 issued at the conclusion of the inspection. We offer following comments:

Your response. item #1, regarding validation of the blood bank computer software did not include a copy of the protocol for our review. The protocol and/or validation summary should include items such as how the system is tested, expected outcomes, whether outcomes were met, worst case scenarios, etc.

Detroit District

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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