Stedim S.A. Sterilizer Software

WARN 11/27/96 Stedim S.A.

Failure to validate software programs by adequate and documented testing, when computers are used as part of an automated production or quality assurance system, as required by 21 CFR 820.61. For example:

The previous inspection revealed that your firm had not performed any validation of the computer software which controls the EO sterilizer. This software was installed in January 1994. A new microprocessor was installed since that time. The new microprocessor could not understand the language of the old software. The old software program was rewritten in a different language to be compatible with the new microprocessor. In addition:

a) There are no formal detailed user defined software requirements specifications that fully describe the intended functions in terms of the inputs, processing, and outputs for each program element.

b) There is no formal software test plan including a description of how test cases were developed and how thorough test coverage was achieved.

c) There is no documented correlation between the users requirements, software functional elements, and software verification activities to assure thorough test coverage.

d) There is no documented evidence that software requirements specifications testing was performed.

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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