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comment Recording data during tests execution
Our quality management system requires objective evidence. Objective evidence has been examined during FDA audit.
comment How to report test progress when you have blocking issues?
You may want to identify approximate percentages for how long each of these phases takes (helps to have historical data) and an estimation of how much time the total task would take (again, some historical data helps a lot). If you can mine any data about how long small vs. medium vs. large projects took in this past, that's a good place to start. Then you can make a prediction on how the current project stacks up against known projects. It's just a prediction, it's not a commitment.
comment For software development in a regulated environment, do use distinguish between essential requirements and detailed requirements?
Thanks for the suggestion of Behavior Driven Development. This is a new term for me. In our environment this would be a high level requirement layer expressed in a way which would allow stakeholders to better express their view of what the system requirements are. This definitely fits in well with the validation phase of testing (was the right system built vs. was the system built right).