03

May

1999

Calypte Biomedical Corp.

0

Failure to investigate the cause of nonconformities relating to product, processes and the quality system; failure to develop, conduct, control and monitor production processes to ensure that a device conforms to its specifications; failure to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality; failure to validate computer software for its intended use according to an established protocol when computer software is used as part of the production or the quality system; failure to establish and maintain procedures for acceptance activities which include inspections, tests or other verification activities; and three other violations.

Failure to validate computer software for its intended use according to an established protocol when computer software is used as part of production or the quality system[21 CFR 820.70(i)] in that the – computer system is not validated for the purpose of shipment of finished goods.

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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