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Archive of Agile and FDA
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New Whitepaper: Agile and High Assurance
Posted on November 13, 2011 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated Environments, High Assurance and ToolingFinally. For those who have been following the High Assurance and Regulated Environments series, I am pleased to announce the completion and publication of the whitepaper: Agile Software Development with Verification and Validation in High Assurance and Regulated Environments. (Click on the image below...
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HIgh Assurance Series Update
Posted on August 2, 2011 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated Environments, High Assurance and ToolingI haven't posted much in this category lately as I've been busy drafting and redrafting the new whitepaper: Agile Software Development with Verification and Validation in High Assurance and Regulated Environments. (Ok, I've been goofing off some, too.) But finally, Craig Langenfeld...
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Tooling for User Story Verification, Part 2
Posted on May 8, 2011 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated Environments, High Assurance and ToolingNote: This post is a continuation of the series on Agile in High Assurance and Regulated Environments. In the last post in this series, Tooling to Automate User Story Verification, I pointed to a post, Tools to Automate User Story...
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Tooling to Automate User Story Verification
Posted on April 16, 2011 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated Environments, High Assurance and ToolingIn a recent post, I noted that Craig Langenfeld, my co-contributor on the Agile in High-Assurance and Regulated Environments series, was beginning to describe how tooling can be used to automate (or semi-automate) much of the formal verification...
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Agile Tooling for High Assurance Development Series: Intro
Posted on March 29, 2011 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated EnvironmentsFor those who have been following the High Assurance and Regulated Environments and Agile and FDA series on this blog, you’ll be interested to note that my co-conspirator, Craig Langenfeld of Rally Software, has committed to describing some...
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Software V&V in High Assurance Agile: Validation: Nonfunctional Requirements
Posted on February 10, 2011 by Dean Leffingwell in Agile and FDA, Agile Requirements, High Assurance and Regulated EnvironmentsBackground: In this series of posts, I’ve been using medical device development (as Regulated by U.S. FDA via CFR 820.30 and international standard IEC62304) as an exemplar for suggesting ways to develop high quality software in regulated (and other...
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Software V&V in High Assurance Agile: Verification: Testing Features
Posted on January 26, 2011 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated EnvironmentsBackground: In this series of posts, I’ve been using medical device development (as Regulated by U.S. FDA via CFR 820.30 and international standard IEC62304) as an exemplar for suggesting ways to develop high quality software in regulated (and other...
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Software V&V in High Assurance Agile Development: Verification: PRD, Features and PRD to SRS Traceability
Posted on January 21, 2011 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated EnvironmentsBackground: In this series of posts, I’ve been using medical device development (as Regulated by U.S. FDA via CFR 820.30 and international standard IEC62304) as an exemplar for suggesting ways to develop high quality software in regulated (and other...
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Software Verification and Validation in High Assurance Agile Development: Validation Sprint
Posted on January 16, 2011 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated EnvironmentsSeries Background: In this series of posts, I’ve been using medical device development (as Regulated by U.S. FDA via CFR 820.30 and international standard IEC62304) as an exemplar for suggesting ways to develop high quality software in regulated (and...
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Additional Perspective on Agile, V&V and FDA
Posted on December 27, 2010 by Dean Leffingwell in Agile and FDABrian Shoemaker, Ph.D., who clearly has expertise on software quality and FDA, (see http://www.shoebarassoc.com/; Brian has more than thirteen years’ experience with software quality and validation in the FDA-regulated industry) added an in-depth comment describing additional documentation guidance for doing software...
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