This whitepaper is taken from Chapter 18 of Scaling Software Agility.

Taken from Chapter 7, The Rational Edge of Scaling Software Agility.

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...
Continue reading this entry →