This is actually how software and systems engineering works in life sciences. There are a set of artifacts which are designated the validation artifacts which

This is actually how software and systems engineering works in life sciences. There are a set of artifacts which are designated the validation artifacts which includes a user requirements specification, functional design specification, technical design specification, and configuration specification. Before any release, the team will start by identifying which of these documents need to be updated and which sections need to be updated. This is codified in a formal, signed document. Then work starts and an updated version of each of the document is created. Prior to releasing the software, the validation process kicks in and basically verifies the correctness of each of those documents in reverse order: the configuration specification -> installation qualification, the functional design specification -> operational qualification, the user requirements specification -> performance qualification (there is no explicit qualification of the technical design). The qualification phase has a mountain of evidence of testing. The result of this rigor is: 1) the products tend to have very low defect rates because every change is accounted for, 2) the release cycle can be as long as the build cycle, 3) it's very hard to fix bugs "on the fly" as these then need to be documented as a deviation and accounted for, 4) anything that breaks is easily accounted for, 5) it's very, very hard for startups to succeed in this space because of how much rigor is required. I initially hated it because I wanted to move fast. But after leading a few release cycles, I could see a lot of the benefits as we rarely "built the wrong thing", we rarely had major defects, and work-life balance was generally pretty good because every release cycle was meticulously scoped since we had to start by describing the planned changes starting from the documentation. There is less scope creep once work on the release starts since the start of the release has already identified what will change and adding scope means adding more paperwork after the fact.