Posted on October 23rd, 2010 by Dean Leffingwell
In 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 regulatory standards that are prevalent in high assurance software development industries. By way of context and [...]
Filed under: Agile and FDA, High Assurance and Regulated Environments | 4 Comments »
Posted on October 15th, 2010 by Dean Leffingwell
During 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, (but the book does a better job of describing it in a more systematic and incremental way). [...]
Filed under: Scaled Agile Framework/Big Picture | 2 Comments »
Posted on October 14th, 2010 by Dean Leffingwell
In 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, Medical and Pharmaceutical industries, as well as providing some guidance for any business which can’t ethically [...]
Filed under: Agile and FDA, High Assurance and Regulated Environments | 10 Comments »
Posted on October 7th, 2010 by Dean Leffingwell
Well, 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 the kerning on the handwriting font we are using to describe user stories….” and “shouldn’t there [...]
Filed under: Agile and FDA, High Assurance and Regulated Environments, Uncategorized | 4 Comments »
