Tag - Software Verification
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Friday, 3 October 2014
By Mitch on Friday, 3 October 2014, 13:58 - Regulations
After a temporary absence, I'm back on the waves with a new series of articles to talk about the files required by the 21 CFR 820 regulations:
- DHF: Design History File,
- DMR: Device Master Record,
- DHR: Device History Record.
Let's begin with the DHF.
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Friday, 14 March 2014
By Mitch on Friday, 14 March 2014, 13:26 - Processes
Validating the compiler used in software development is a recurring issue. To what extent a compiler should be validated, when, how and why?
In the same vein, we can extend the question of validation to all tools used in the software development environment: integrated development environment, configuration management tools, compiler (and linker), automated test tools.
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Friday, 28 February 2014
By Mitch on Friday, 28 February 2014, 13:49 - Processes
If you've haven't heard about Apple's security flaw registered as CVE-2014-1266 on apple website, you probably were on planet Mars.
Basically, it was unsafe to use https connections. I couldn't help but write an article about this!
Components dealing with secured connections are abolutely critical. Applying rigorous development process is the best chance to avoid any trouble with these components.
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Friday, 25 October 2013
By Mitch on Friday, 25 October 2013, 19:05 - Processes
Software testing is the keystone of bugs discovery. Most of software engineers and project managers think this assertion is true!
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Friday, 11 October 2013
By Mitch on Friday, 11 October 2013, 14:08 - Processes
Your company develops medical web apps (HTML/JS, HTML5 or any other client-side technology) and your customers would like them to run on every web browser.
Web browsers are SOUP, according to IEC 62304. In case of Chrome and Firefox there are dozens of versions...
Does it mean that software has to be tested - and documented - with every single browser and every single version of the browser?
That's a nightmare!
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Friday, 13 September 2013
By Mitch on Friday, 13 September 2013, 13:22 - Templates
Here is an update of Software Test Plan, Software Test Description, and Software Test Report templates.
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Friday, 14 December 2012
By Mitch on Friday, 14 December 2012, 12:35 - Processes
In my last post, I explained the benefits of static analysis. This software verification method is mainly relevant to find bugs in mission critical software. But it fits the need of bug-free software for less critical software as well.
Static analysis can be seen as an achievement in the implementation of software verification methods. Yet, other methods exists that fit very specific purposes.
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Friday, 7 December 2012
By Mitch on Friday, 7 December 2012, 12:45 - Processes
In my last article, I talked about the most classical methods used to verify software: human testing (driven by test cases or not) and unit tests. I was about to talk about static analysis, that I place at a higher level of complexity in the list of verification methods, but I have to say a bit more about unit tests.
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Friday, 30 November 2012
By Mitch on Friday, 30 November 2012, 12:06 - Processes
Software verification is easy to define: to demonstrate that software works as it was specified (and without bugs!). But there's not a unique way to do it.
Let's see what methods we have in hands to verify software.
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Friday, 16 November 2012
By Mitch on Friday, 16 November 2012, 12:34 - Processes
Writing about V&V in two previous posts, I had a lot of comments from people on a well-known social network. They made corrections to my view of V&V and brought their own definitions.
Here is an excerpt of their comments.
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Friday, 2 November 2012
By Mitch on Friday, 2 November 2012, 14:11 - Processes
Following the article about software verification, let's see what software validation is.
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Friday, 26 October 2012
By Mitch on Friday, 26 October 2012, 14:09 - Processes
Many people make the confusion between verification and validation. There is no exception for software! I'd even say that the confusion is even worse for standalone software.
Let's see first the definition of verification and validation. I borrowed these definitions from the FDA website:
- Verification is confirming that design output meets the design input requirements,
- Validation is ensuring that the device conforms to defined user needs and intended uses.
OK, this remains theoretical. How to do that with software medical devices?
In this article I focus on verification and will focus on validation in the next article: What is software validation.
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