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Archive of 2010 December
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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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Software Verification and Validation in High Assurance Agile Development: Verification: SRS and User Stories
Posted on December 17, 2010 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...
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Software Verification and Validation in High Assurance Agile Development: Ground Rules
Posted on December 4, 2010 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...
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Resource Flexibility in The Agile Enterprise
Posted on December 2, 2010 by Dean Leffingwell in Enterprise Rollout, Feature Vs Component Teams, Release Planning, Team PracticesI received this interesting email from a colleague (who allowed me to share it) a few days back. “I currently lead a project on how to increase our resource fluidity so that we can effectively assign sufficient manpower to where it matters...
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