I have a career spanning more than 15 years building Quality Management Systems to develop a variety of products including single use medical devices, in-vitro diagnostics (with machine learning integrated software), and combination products in US and European markets. In that time I have learned that while the ultimate goal is compliance to applicable regulations, compliance for the sake of compliance is ineffective if it comes at the cost of unreasonably slowing development and innovation. Procedures should work with the team, not against it.