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Archive of 2010 October
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Agile Development in Regulated Environments Example: Medical Devices – Waterfall Lifecyle Model
Posted on October 23, 2010 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated EnvironmentsIn an earlier post, I noted that I would be using the FDA CFR 21 820.30 regulations as our example “stalking horse” to try to develop a reasonable and logical way of conforming agile development to these, and similar...
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The Agile Enterprise Big Picture Graphic (revised,again).
Posted on October 15, 2010 by Dean Leffingwell in Scaled Agile Framework/Big PictureDuring the course of finalizing the Agile Software Requirements book, the Agile Enterprise Big Picture graphic has undergone some minor changes and has been revised for the umpteenth time. The blog series/category on the Big Picture is here,...
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Agile Software Development in Regulated Environments Example: Medical Devices
Posted on October 14, 2010 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated EnvironmentsIn the last post, I introduced this blog series and category wherein I'll be describing agile approaches to developing high assurance software in regulated environments. This series is intended for those who do such development in the Avionics, Defense,...
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New Blog Series: High Assurance Agile Development in Regulated Environments
Posted on October 7, 2010 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated Environments, UncategorizedWell, I’ve about wrapped up the book Agile Software Requirements: Lean Requirements Practices for Teams, Programs, and the Enterprise, at Addison-Wesley. Still working through the thousand nits and nats required to get it into print “hey, can we tighten...
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