Archive for Process
The FDA has just published a new draft of guidance about mobile technology in FDA-regulated systems. This guidance is open for comment and isn’t binding yet.
So, what does this mean for testing FDA-regulated products with mobile technology?
The draft guidance defines when mobile platforms are considered as part of a regulated system or not. The criteria for inclusion…
A Chicago Tribune article recounts how a software bug in an infusion pump lead to brain-death for a patient in 2009 (“Medical Industry Taking Hard Look at Software Faults,” Christine Mai-Duc, Chicago Tribune, August 31, 2011, p. 19)
It reports that the US Food and Drug Administration (FDA), which regulates and…
This post covers part three of my 2010 talk on testability.
Aren’t the dancing hamsters a stitch?
Not so funny if you have to test code whose stability or controllability makes you feel like you’re wearing the hula-hoop.
To reveal a bug, a test must:
Reach the buggy code
Trigger the bug
Propagate the incorrect result to an observable interface
Incorrect…
Once upon a time, I had a Software 25 company with a struggling division as a client. They were selling and supporting an integrated enterprise system brought in by acquisition. This product, at version 7.0, was dominant in its market. But, with apologies to Gresham, bad software was driving out…
Read MoreAfter proving that good project management and software engineering could result in on-time, in-budget, high quality results for contract software development, I was designated as the project manager of a large fixed-price development project. Despite my objections, a second project manager was also assigned to this project. The relationship was explained as…
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