Posted on December 27th, 2010 by Dean Leffingwell
Brian 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 V&V. He also provides his opinion on applicability of agile in this world (just do it?) [...]
Filed under: Agile and FDA | 1 Comment »
Posted on December 17th, 2010 by Dean Leffingwell
Series 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 other high assurance, high economic cost of failure) environments in an agile manner. This series is [...]
Filed under: Agile and FDA, High Assurance and Regulated Environments | 1 Comment »
Posted on December 4th, 2010 by Dean Leffingwell
Series 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 other high assurance, high economic cost of failure) environments in an agile manner. This series is [...]
Filed under: Agile and FDA, High Assurance and Regulated Environments | No Comments »
Posted on December 2nd, 2010 by Dean Leffingwell
I 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 the most, e.g. working on the highest priority items on the backlog. We acknowledge [...]
Filed under: Enterprise Rollout, Feature Vs Component Teams, Release Planning, Team Practices | 4 Comments »
