Prompted by this tweet from Jean Ann Harrison
Based on my own experience so far in FDA regulated companies it is really difficult to have agile practices in those environments. Equally waterfall based approaches can end up costing a lot of money when they fail at the end of the process. I’ve worked on a project where it was waterfall based and the deadline was forever being pushed later and later due to complications that could not have been foreseen. More recently I worked on a project where we had sprints and testing throughout but the release of the product was more of a waterfall type with a deadline in X months to deliver to customers.
Are there ways to build agility into regulated testing projects?
Are there any things that you have encountered that you would forewarn people about?