> One thing that jumped out to me reading the article was the author’s (or the organization’s) aversion to writing requirement spec (“detailed documentation”).

> One thing that jumped out to me reading the article was the author’s (or the organization’s) aversion to writing requirement spec (“detailed documentation”). That sounded very worrisome particularly considering the fact that the development was for a domain like that of Pharma, where rules & regulations shadows heavily on what and how things are done. He addressed that early on -- he mentioned that much of the development was "brochureware" websites. Don't think the FDA gives a wet rat about that.