Aug

1998

Allergy Laboratories

Allergy Laboratories 8/14/98

4. Failure to routinely calibrate, inspect, or check for accuracy and to exercise appropriate controls for automatic, mechanical, or electronic equipment or other types of equipment, including computers, used in the manufacture, processing, packaging, and holding of a drug product according to a written program designed so as to assure performance [21 CFR 211.68], in that:
a. thermometers which are used to monitor the temperature of the WFI system are not calibrated.

b. thermocouples which were used in the heat distribution study of the autoclave were not calibrated.

c. the xxxx Computer database and computer program used for inventory tracking and distribution of final product has not been validated.

d. Installation Qualification (IQ), Operation Qualification (OQ), and worst case operating conditions were not performed as part of the validation study for the incubator.

SoftwareCPR keywords: software validation, CBER, CDER, Drugs, Pharma

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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Amy Sellers

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