Trying to understand Software Design Verification … A QA’s takeaway on reading the General Principles of Software Validation for the first time. FDA gives guidance in the General Principles of Software Validation guidance document, but in general: Testing at different levels: units, integrated units, software complete Testing types: negative, combinatorial, fault injection, risk controls challenge, boundary, corner cases, stress,...Read More

This post discusses some code review basics – concepts and inspection ideas that one might use when performing a code review.  A code review is a technical verification activity.  The purpose is most often to identify coding errors against the design intent – one is verifying that the code actually accomplishes what that author intended....Read More

September 17, 2021 CMS 617922 Excerpts from a warning letter of interest to software professionals: “The United States Food and Drug Administration (FDA) conducted an inspection of your medical device operations at 200 W. Mercer Street, Suite 500, Seattle, WA 98119 from June 3, 2021 through July 15, 2021. During the inspection, an FDA Investigator...Read More

Going way back to the late 1990’s, FDA had an expectation that safe and effective software would require a well thought out development lifecycle that includes many activities designed to ensure the correctness and robustness of all software that was part of the medical device.  A key guidance document was created known as the General...Read More

The latest ACM Journal has an interesting article on software verification at NASA JPL for the Mars Curiosity Rover at the link provided: Mars Code February 2014Read More

The link provided is to an article on Fuzz testing. This type of testing involves injecting bad data to challenge your applications and safeguards. This type of testing can be important to verify risk control measures and data integrity checks are verified. The name Fuzz testing is a fairly recent moniker for techniques that have...Read More

The pdf at the link provided is a reprint of an article entitled “Software Test Coverage” authored by Alan Kusinitz, Managing Partner of SoftwareCPR, for the AAMI Biomedical Instrumentation and Technology journal and published in the Spring of 2003. AAMI-BIT-Software-Test-Coverage ArticleRead More